Guidelines to the Treatment of Chronic Kidney Disease with Hemodialysis

inSaudi Arabia

2006

Preface

Guidelines for the management of chronic kidney disease (CKD) patients by hemodialysis (HD) have been developed worldwide to help care takers of this population manage their patients in a better quality conditions. The renal community in Saudi Arabia may feel that such guidelines are timely required based on current surveys conducted by the Saudi Center for Organ Transplantation (SCOT). A committee of the distinguished leaders in the field of Nephrology in Saudi Arabia was formed by the SCOT to establish the guidelines for the management of CKD patients by HD and their input is highly appreciated. We included in this supplement the prominent studies that were carried out in Saudi Arabia and categorized the guidelines into HD management in the light of international experience in this topic. We have already published guidelines about the management of anemia and bone disease in the HD patients; that is why we did not include them in the guidelines in this booklet. We hope that this work guides the dialysis centers in Saudi Arabia to establish specific protocols for hemodialysis management and look forward to update them regularly.

Faissal A.M. Shaheen MD.,Muhammad Ziad Souqiyyeh MD.,

On behalf of the advisory committeefor the management of anemia

Advisory Committee for the Management of Anemia in Chronic Kidney disease Patients

Dr. Othman AlfureyhDivision of Nephrology,Department of Medicine,King Faissal Specialist hospital & Research Center,Riyadh.

Dr. Saeed AlGhamidiDivision of Nephrology,Department of Medicine,King Faisal Specialist Hospital,Jeddah

Dr. Ali AlharbiDivision of Nephrology,Department Of Medicine,Security Forces Hospital,Riyadh.

Dr. Khaled AlmeshariDepartment of Medicine,King Faissal Specialist hospital & Research Center,Riyadh.

Dr. Abdulla Alkhader AlsayyariDivision of Nephrology,Department of Medicine,King Fahd National Guard Hospital,Riyadh

Dr. Mohammad AlsulaimanDivision of Nephrology,Department of Medicine,Armed Forces HospitalRiyadh

Prof. Jamal Al-WakeelDivision of Nephrology,Department of Medicine,King Kaled University Hospital,Riyadh.

Dr. Ayman KarkarDivision of Nephrology,Department of Medicine,Dammam Central Hospital,Dammam

Dr. Ali LehbiDivision of Nephrology,Department of Medicine,King Faissal Specialist hospital & Research Center,Riyadh.

Dr. Saadi TaherDepartment of Medicine,King Fahd National Guard hospital Riyadh.

Contents

Topic Page

Introduction 1

Treatment of CKD patients by hemodialysis in Saudi Arabia 2

Guidelines Statements 8

I. Initiation of Hemodialysis 9

II. Patients' education 13

III. Set-up for Hemodialysis 14

IV. Vascular Access for Hemodialysis 22

V. Adequacy of Hemodialysis 39

VI.Common Infections in HD Patients 46

VII. Cardiovascular Risk Factors in Hemodialysis patients 49

References 52

ii

Introduction

Dialysis is a known modality of renal replacement therapy that is available worldwide. Chronic kidney disease (CKD) patients in the advanced stages would require dialysis at certain level during stage 5 of the disease. 1 Accurate estimation of the glomerular filtration rate should be evaluated in the high risk patients such as hypertensive and diabetic patients, and early CKD stages followed by early referral to nephrologists not later than stage 2-3 according to the availability of appropriate resources.2,3 The best methods of estimation of GFR should be praticed. 4-10Any evidence of malnutrition should be a reason to start dialysis early if the patient has reached CKD stage 5. 11-15 Other factors such as hypertension, anemia, dyslipidemia, diabetes, and derangements of mineral metabolism can affect the progression of CKD and should be addressed as well.16-21 Perspectives should be discussed early with patients about the best option of therapy. 22-27

Patients’ education is a very impotant initial step that has enables the patients to make informed decision for their future.28-32

The set-up of the dialysis centers involves the personnel and machinery. Audits about performance of any dialysis center should take into account the resources available in that center. Respect of the qualifications and ratios of the different nephrology team members to the volume of work in any dialysis center is a key to good quality care. 33-49 The choice of the machines and their maintenance should be according to the guidelines and best available versions in the market.50

The quality of the treated water for hemodialysis and design of the water treatment plants should follow the international standards.51-58

The choice of the dialyzers and solutions for dialysis have been guided by many studies that favored the synthetic membranes and bicarbonate dialysis mode.59-70 The use of anticoagulants during dialysis has been under great scrutiny since we do not have an ideal agent uptill now despite the development of the more convenient low molecular weight heparins.71-76 The vascular access for hemodialysis has been most time consuming problem in dialysis units. The creation and maintenance of functioning access is a major step towards dialysis adequacy.77 The tools for early detection of inadequate accesses and managements are widely

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available. These include the measurement of blood flow and pressure of the accesses, whether it is a graft or fistula.78-81 Temporary accesses involve catheters of different configurations and insertion sites. 82,83

The catheters as accesses for hemodialysis have always been inferior in their quality and prognosis to the grafts or fistulae. Early creation of fistulae is the gold standard practice and audits should follow this guideline. 84 Guidelines for prevention of infection, steonsis, thrombosis, and development of aneurysms of accesses should be established in the dialysis centers and followed strictly to avoid loss of access that compromises the adequacy of dialysis and may result in patients’ morbidity and mortality .85-100

Estimation of adequacy of dialysis depends not only on the accurate measurement of the small solute clearance such as urea clearance per unit of body volume (KT/V), but also involves the management of the patient as a whole such as control of hypertension, anemia and bone disease. The guidelines for measurement of KT/V and dialysis dose involve the accurate method of sampling of urea, dialyzer estimated clearance, time of the dialysis session, and modeling for the solute clearance (single pool or double pool).101-134 There are other areas of concen in the management of hemodialysis patients such as the common infections in the dialysis center. These include transmittable disease such as viral hepatitis, tuberculosis .135-152

survillance, prophylaxis, prevention, and treatment for these infections should be guided and maintained in the different dialysis centers.153-157

The cardiovascular disease in the dialysis patients is of great importance since it is responsible for the highest percentage of mortality in population.15 Conventional risk factors such as smoking, hyperlipidemia, anemia, diabetes, and hypertension can be modified. Other non-conventional factors such as systemic inflammation secondary to infectious and non-infectious factors such as oxidative stresses and homocystein, dialysis membranes, minerals abnormalities can be modified as well.158-208 Guidelines for control of these factors should be followed up and addressed by the care takers besides the other procedures of dialysis.

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Treatment of CKD patients by Hemodialysis in Saudi Arabia

1.In 1990, al-Mohaya et al209 reported about fistulas in dialysis patients. Arterio-venous fistula of Brescia was created in 112 consecutive patients during a five year period from May 1983 at King Fahd University Hospital of King Faisal University, Al-Khobar, Saudi Arabia.

2.In1990, Mattoo et al210 reported about temporary access for dialysis in children.

3.In 1990, Adiku et al 211reported about the concentration of sodium in the hemodialysate.

4.In 1990, Shaheen et al212 reported the results of subclavian catheters as access for hemodialysis.

5.In 1990, El Tayeb et al213 reported a case of bleeding during dialysis. 6.In 1991, Mahmoud et al214 reported their experience on hemodialysis of

children in Saudi Arabia. 7.In 1991, Sulimani et al215 repoted about isoniazid induced acute confusional

state in a patient on hemodialysis. 8.In 1991, Ayoola et al216 reported about the prevalence and significance of

antibodies to hepatitis C virus among Saudi hemodialysis patients. 9.In 1991, Mitwalli 217reported about tuberculosis in patients on maintenance

dialysis. 10.In 1991, George et al218 reported a clinical study of permanent vascular

access in hemodialysis patients. 11.In 1991, Souqiyyeh et al219 reported a case of postpartum hemolytic-uremic

syndrome. 12.In 1991, Aldrees et al220 reported about the cost evaluation of hemodialysis

in ministry of health hospitals, Saudi Arabia. 13.In 1992, Souqiyyeh et al221 reported about pregnancy in chronic

hemodialysis patients in the Kingdom of Saudi Arabia. 14.In 1992, Hussein et al222 reported about the spectrum of pericarditis among

hemodialysis patients experience in a single center. 15.In 1992, Mahmoud et al223 reported about the intra-atrial permanent

catheter: A long-term vascular access for hemodialysis in small children. 16.In 1993, Hussein et al224 reported about the use of biocompatible

membrane (AN 69) dialyzers in chronic hemodialysis patients. 17.In 1994, Hussein et al225 reported their observations in a Saudi-Arabian

dialysis population over a 13-year period. 18.Al-Koussi et al226 reported about uremia and hemodialysis effects on

plasma levels of circulating TNF-α. 19.In 1994, Al Shohaib et227 al reported about the complications of subclavian

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catheterization in hemodialysis patients. 20.In 1995, Huraib et al228 reported about the high prevalence of and risk

factors for hepatitis C in hemodialysis patients in Saudi Arabia: a need for new dialysis strategies.

21.In 1995, al-Faleh et al229 reported about hepatitis C virus genotypes in patients with chronic liver disease and hemodialysis patients from Saudi Arabia.

22.In 1995, Ahmad et al230 reported about the prevalence of antibodies against the hepatitis C virus among voluntary blood donors at a Makkah hospital.

23.In 1995, Al-Muhanna FA.231 Hepatitis C virus infection among hemodialysis patients in the eastern region of Saudi Arabia.

24.In 1995, Al Shohaib et al232 reported about the prevalence of hepatitis C virus antibodies among hemodialysis patients in Jeddah area, Saudi Arabia.

25.In 1995, Bernieh et al233 reported about the prevalence of hepatitis C virus antibodies in hemodialysis patients in Madinah Al Munawarah.

26.In 1995, Shaheen et al234 reported about the prevalence of hepatitis C antibodies among hemodialysis patients in the Western Province of Saudi Arabia.

27.In 1995, Omer et al235 reported about the liver enzymes and protein electrophoretic patterns in hemodialysis patients with antibodies against the hepatitis C virus.

28.In 1995, Souqiyyeh et al236 reported about the annual incidence of seroconversion of antibodies to the hepatitis C virus in the hemodialysis population in Saudi Arabia.

29.In 1995, Abu-Aisha et al237 reported about the effect of chemical and heat disinfection of the hemodialysis machines on the spread of hepatitis C virus infection: A prospective study.

30.In 1995, Qattan et al238 reported about the grafts for hemodialysis access: Results and complications.

31.In 1996, Souqiyyeh et al239 reported about the role of computers in coordination of renal care facilities: experience in the Kingdom of Saudi Arabia.

32.In 1996, Soyannwo et al240 reported about hepatitis C antibodies in hemodialysis and pattern of end-stage renal failure in Gassim, Saudi Arabia.

33.In 1996 Al-Mugeiren et241 al reported about hepatitis C virus infection in two groups of pediatric patients: one maintained on hemodialysis and the other on continuous ambulatory peritoneal dialysis.

34.In 1997, Al-Homrany242 reported about successful therapy of tuberculosis in hemodialysis patients.

35.In 1997, Kumar et al243 reported about acquired cystic renal disease in patients receiving long-term hemodialysis.

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36.In 1997, Sulaiman 244reported about pregnancy in hemodialysis patients. 37.In 1997, Al-Salman et al245 reported about central vein stenosis in patients

with prior subclavian vein catheterization for maintenance dialysis. 38.In 1997, Kumar246 reported about hepatitis C virus infection among

hemodialysis patients in the Najran Region of Saudi Arabia. 39.1n 1998, Taminu et al247 reported about Doppler ultrasound evaluation of

hemodialysis vascular access. 40.In 1998, Al-Wakeel248 reported about post-dialysis solutes rebound:

comparison of two protocols for hemodialysis. 41.In 1999, Al-Homrany et al249 reported about fatal complication of

percutaneous femoral vein catheterization in a hemodialysis patient. 42.In 1999. Al Shohaib250 reported about tuberculosis in chronic renal failure

in Jeddah. 43.al-Muhanna et al251 reported about disease profile, complications and

outcome in patients on maintenance hemodialysis at King Faisal University Hospital, Saudi Arabia.

44.In 2000, Mohamed et al252 reported about patients on hemodialysis visiting Madina Munawarah: Communication between nephrologists.

45.In 2000, Jamal et al253 reported about nail changes in end-stage renal failure patients on hemodialysis.

46.In 2000, Jamal et al254 reported about pruritus among end-stage renal failure patients on hemodialysis.

47.In 2000, Tanimu et al255 reported about the effect of vitamin E-modified dialyzers on acute intra-dialytic symptoms: a comparative crossover study.

48.In 2000, Al-Salman et al256 reported about effect of arteriovenous fistula for hemodialysis on limb circulation.

49.In 2000, Al Shohaib et al257 reported about tuberculous peritonitis in hemodialysis patients with chronic liver disease.

50.In 2001, Al-Ghamdi et al 258reported about hepatitis C virus sero-status in hemodialysis patients returning from holiday: another risk factor for HCV transmission.

51.In 2001, Subramanian et al259 reported about hemodialysis utilization in a single in-center dialysis unit in the Kingdom of Saudi Arabia.

52.In 2001, Al-Homrany et al260 reported about psycho-social features of chronic dialysis patients in Saudi Arabia: experience of one center.

53.In 2001,Al Dayel et al261 studied the stretch polytetrafluoroethylene grafts for hmodialysis agioaccess: Three-year experience.

54.In 2001, Souqiyyeh et al262 reported about dialysis centers in the kingdom of Saudi Arabia.

55.In 2001,Mitwalli A H., et al263 reported about dialyzer reuse impact on dialyzer efficiency, patient morbidity and mortality and cost effectiveness.

5

56.In 2001, Al-Khader et al264 reported about the need for guidelines for the practice of hemodialysis in the Kingdom of Saudi Arabia: a questionnaire Survey.

57.In 2002, Saxena et al265 reported about nosocomial transmission of syphilis during hemodialysis in a developing country.

58.In 2002, Saxena et al266 reported about outcome of dialysis access-related septicemia among diabetics following optimized AV-fistula placement.

59.In 2002, Ayoola EA et al267 Hepatitis E virus infection in hemodialysis patients: a case-control study in Saudi Arabia.

60.In 2002, Saeed et al268 reported about the prospective study of hemodialysis access-related bacterial infections.

61.In 2002, Dahduli et al269 reported about mobilization and superficialization of basilic vein for brachio basilic fistula.

62.In 2002, Bhat et al270 reported about nosocomial infective endocarditis in hemodialysis.

63.In 2002, Al Wakeel et al271 reported about morbidity and mortality in ESRD patients on dialysis.

64.In 2003, Saxena et al272 reported about impact of dedicated space, dialysis equipment, and nursing staff on the transmission of hepatitis C virus in a hemodialysis unit of the Middle East.

65.In 2003, Al-Jondeby et al273 reported about comparative crossover controlled study using polysulphone and vitamin E coated dialyzers.

66.In 2003, Bouraoui et al274 reported about the predictors of early mortality in patients starting chronic hemodialysis.

67.In 2003, Saxena et al275 reported about the prevalence of nasal carriage of Staphylococcus aureus and associated vascular access-related septicemia among patients on hemodialysis in Al-Hasa Region of Saudi Arabia.

68.In 2003, Al-Jiffri et al276 reported about hepatitis C virus infection among patients on hemodialysis in Jeddah: a single center experience.

69.In 2003, Abul Kashem et al277 reported about hepatitis C Virus among hemodialysis patients in Najran: Prevalence is more among multi-center visitors.

70.In 2003, Souqiyyeh et al278 reported about the attitude of physicians in Saudi Arabia towards heparin administration and monitoring in hemodialysis patients.

71.In 2004, Saxena et al279 reported about the vulnerability of middle-aged and elderly patients to hepatitis C virus infection in a high-prevalence hospital-based hemodialysis setting.

72.In 2004, Saxena et al280 reported about the impact of nurse understaffing on the transmission of hepatitis C virus in a hospital-based hemodialysis unit.

73.In 2004, Saxena et al281 reported about advancing age and the risk of nasal

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carriage of Staphylococcus aureus among patients on long-term hospital-based hemodialysis.

74.In 2004 Al-Ghamdi282 reported about nurses’ knowledge and practice in hemodialysis units: comparison between nurses in units with high and low prevalence of hepatitis C virus Infection.

75.In 2004, Raza et al283 reported about the effect of active nutritional counseling in improving biochemical nutritional parameters and fluid overload problems in maintenance hemodialysis patients.

76.In 2004, Sobki et al284 reported about. effect of age on pituitary gonadal hormonal responses of Saudi male patients on hemodialysis.

77.In 2005, Shaheen et al285 reported about a comparative psychosocial analysis of patients on maintenance hemodialysis and transplanted patients.

78.In 2005, Malik et al286 reported about pregnancy in patients on dialysis experience at a referral center.

79.In 2005, Mitwalli et al287 reported about L-Carnitine Supplementation in Hemodialysis.

80.In 2005, Badawi et al288 reported about dose and lipid lowering effect of tinzaparin sodium: a single center experience.

81.In 2005, Al-Harbi et al289 reported about treatment of acute hepatitis C virus infection with alpha interferon in patients on hemodialysis.

82.In 2005, Mohamed290 reported about Morbidity and mortality in ESRD patients on regular hemodialysis: a single center experience.

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G U I D E L I N E SG U I D E L I N E SS T A T E M E N T S

8

I. Initiation of Hemodialysis

A. Residual renal function should be reported as glomerular filtration rate (GFR) and expressed in ml/min/ 1.73 m2 as in in the chonic kidney disease patients.

B. Referral to nephrology should be considered when the GFR is ≤60 ml/min and is mandatory when the GFR is ≤30 ml/min.

C. Dialysis can be initiated when GFR falls below 15 ml/min/1.73 m2

if there is evidence of uremia or its complications such as malnutrition.

D. If there is no evidence of uremia or its complications including malnutrition, initiate dialysis when GFR falls below approximately 10 mL/min/1.73 m2.

E. To encourage informed decision making, educate patients and staff about the strength of the evidence (at best, cohort studies) regarding the rationale for 'early' dialysis initiation.

F. Monitor GFR quarterly from value of 15-20 ml/min/1.73 m2 and monthly from < 15 ml/min/1.73 m2 to avoid unintentional delay in initiation of dialysis.

G. With regards to measurement of renal function: GFR calculated as the mean of urea and creatinine clearance can be corrected for body surface area (BSA) by multiplying the uncorrected GFR by1.73/BSA.

H. BSA can be determined from the formula of Du Bois: BSA = 0.007184 x [height (cm)] 0.725 x [weight (kg)]0.425.

I. Creatinine clearance to determine the need for initiating dialysis should not be relied on solely because of the wide variations due to extrarenal creatinine clearance and renal creatinine secretion.

J. Target urea clearance can be calculated from the formula: ureaclear

L/wk) = 2.0 (target weekly Kt/V) x Weight (kg) x 0.58 K. V is calculated as (Weight (kg) x 0.58) in this equation. It can be

more accurately determined from the formulae of Watson : 1.For males V = 2.477 + [0.3362 x Weight (kg)] + [0.1074 x Height (cm)] - [0.09516 x age]2.For females V = -2.097 + [0.2466 x Weight (kg)] + [0.1069 x Height (cm)]

9

3.for children V can be calculated using the Mellits-Cheek method:

a) For Boys: V (liters) = -1.927 +0.465*Wt (kg) + 0.045*Ht (cm), when Ht < 132.7 cm. V= -21.993 + 0.406* Wt + 0.209*Ht, when height is > 132.7 cm.

b) b. For Girls: V = 0.076 + 0.507*Wt + 0.013*Ht, when height is < 110.8 cm. V = -10.313 + 0.252* Wt + 0.154*Ht, when height is >110.8 cm

L. Primary determinants of mode of initial dialysis include the preference of a fully-informed patient, absence of medical and surgical contra-indications, and resource availability.

Peritoneal dialysis contraindications:1. Previous abdominal surgery with adhesions2. Unrepaired hernia.3. Pleuro-peritoneal communication.4. Bowel problems (e.g. chronic constipation, diverticulitis).5. Severe respiratory insufficiency.6. Ileal conduit or colostomy.7. Abdominal obesity.8. Large muscle mass.Hemodialysis contraindications:1. Vasculature unsuitable for AV fistula.2. Cardiovascular instability.3. Needle phobia.

M. When dialysis modality is not determined by preference of a fully-informed patient, absence of medical and surgical contraindications and resource availability, consider using continuous ambulatory peritoneal dialysis (CAPD) in preference to hemodialysis to better preserve residual renal function (RRF) and allow graded introduction of dialysis.

N. Dialysis should be initiated at first indication of malnutrition suspected to be due to uremia and unresponsive to dietary intervention or correction of other reversible causes.

O. Evidence of malnutrition should be sought for once a GFR of 15 mL/min/1.73 m2 is found, and monthly from GFR < 10 mL/min/1.73 m2.

P. Absolute indications' for dialysis initiation is a historical concept,

10

which is no longer valid, and their presence suggests delayed initiation. However, in some patients with comorbid conditions, dialysis may be indicated for these reasons even when GFR is greater than 10 mL/min/1.73m2. Traditional absolute indicators include:

1. Pericarditis. 2. Fluid overload.3. Hypertension poorly responsive to non-dialytic treatment.4. Hyperkalaemia. 5. Acidosis.6. Advanced uremic encephalopathy and/or neuropathy. 7. Significant bleeding diathesis. 8. Severe nausea and vomiting.

Q. Similarly, traditional 'relative indications' may not be useful because they are largely subjective and depend on patient perception and acceptance, and may be due to intercurrent diseases. Traditional relative indications include:

1. Anorexia.2. Profound fatigue and weakness.3. Impaired cognition, memory and attention span.4. Severe pruritus.5. Depression and poor interpersonal relationships.

R. For patients in nitrogen balance, dietary nitrogen (protein) intake (DPI) is equivalent to protein catabolic rate (PCR) + protein losses or urinary and non-urinary nitrogen appearance (PNA) + protein losses.

S. Approximate normalised PCR (nPCR) may be calculated by the Randerson equation :

1.nPCR (g/kg/d) = {[urea excretion (mmol/d) x 0.209] + 15.71} x weight (kg)2.For children, plasma nitrogen appearance (PNA) can be derived by the modified Borah formula PNA (g/d) = [urea excretion (mmol/d) x 0.209] + 0.294 x [V (total body water in litres)] + protein

11

losses.T. Corrected DPI can be calculated by multiplying nPCR by

actual/ideal body weight. Malnutrition may be suggested by:

1.Fall in lean body mass.2.Fall in serum albumin.3.Serum albumin below the lower limit of the reference range.4.Normalized nPCR < 0.8 g/kg/d.5.Subjective global assessment (SGA).

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II. Patients’ Education

A. Patients and their families or carers should receive sufficient information and education regarding the nature of end-stage kidney disease (ESKD), and the options for the treatment to allow them to make an informed decision about the management of their ESKD.

B. The use of multidisciplinary clinics with input from medical, nursing and allied health personnel using standardised protocols for the preparation of patients for dialysis is one way of achieving this outcome.

C. Predialysis education programmes providing information about kidney disease, options for the management of chronic kidney disease (CKD) prior to dialysis including:

1.Pharamacological and dietary management.2. The options for renal replacement therapy may also be beneficial.

D. Education programmes should incorporate:1.A mechanism for the timely referral of patients for the creation of

an access for dialysis( better control of anemia and hypertension).2.Greater patient involvement in the selection of the mode of

dialysis.3.A reduction in the need for 'urgent start' dialysis.4.Improved short-term survival and quality of life after the

initiation of dialysis.

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III. Set-up for dialysis

1. PersonnelA. Specialists or consultants in Nephrology. The ratio should be at

least one physicain to every 50 chronic dialysis patients (maximum).

B. Physicians with fewer ratios to patients may take part in the medical department activities.

C. The activities of the specialists may include training, audits, research and procedures.

D. The minimum expected procedures to be performed by the specialists include kidney biopsies and acute access for dialysis.

E. Nurses or dialysis technicians: with a maximum ratio of one nurse to every three patients.

F. Dietitian: One to every 100 patients (full time).G. Social worker: one to every 100 patients (full time).

2. Dialysis Unit designA. Place should be spacious.Every patient should have at least 7

square meters of space for him and his machine. More than 20 machines in one unit should be discouraged if possible.

3. Water qualityA. The chemical and bacteriological purity of the dialysis water must

be monitored routinely and regularly and the results should be documented. There should be documented procedures, which come into effect once these limits are exceeded. These procedures will include temporary closure of the dialysis unit when the safe limits for contaminants are exceeded.

B. Ultrapure water may reduce long-term risk of accelerated vascular damage, improve response to erythropoetic agents and reduce catabolic nutritional state.

C. Infusion fluid for hemodiafiltration or hemofiltration must be produced with strict observance of the manufacturer's validated process. Final filtration must ensure 7 log reductions in bacterial count of ultrapure fluid.

D. European guidelines is preferable to be the basis for optimal

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dialysate production than those of the Association for the Advancement of Medical Instrumentation (AAMI) guidelines

E. AAMI guidelines recommendations:1. Water: bacterial count < 200 CFU/mL; > 50 CFU/mL warrants

corrective action.2. Endotoxin count < 2 IU/mL; > 1 EU/mL warrants corrective

action. 3. Ultrapure: bacterial count < 0.1 CFU/mL; Endotoxin < 0.03

EU/mL.F. European Pharmacopoeia standards:

1. Water: bacterial count: regular < 100 CFU/mL; ultrapure < 0.1 CFU/mL (High flux dialysis or on-line fluid production).

2. Endotoxin count: regular < 0.25 EU/mL; ultrapure < 0.03 EU/mL.

G. Monitoring the microbiology of the water feeding dialysis machine should be performed weekly during the validation phase and at least monthly during the surveillance period

H. Regular and effective disinfection procedures are an integral part of the hygienic maintenance of the water treatment system. Periodicity, type of disinfection (chemical, heat, mixed), periodic changes of components (filters, resins, filters) should be performed in accordance with manufacturer recommendations and adapted to microbiology monitoring results. Complete disinfection of the water treatment chain should be performed at least monthly.

I. The most frequently used components are represented by mechanical filters, oxidizing filters, cartridge filters, ultrafilters, carbon filters, ion exchanger and reverse osmosis units.

J. Reverse osmosis removes virtually all organic compounds; 90 to 99% of all ions, and 99.9% of viruses, bacteria and pyrogens.

K. The allowable chemical contami-nants levels are included in the following table:

15

Substance (ppm) European Pharmaco-

AAMI

Aluminum 0.01 0.01Ammonium 0.2Antimony 0.005Arsenic 0.005Barium 0.1Beryl 0.0004

Cadmium 0.001Calcium 2 2Cyanide 0.02Chlorine (free) 0.5Chlorine (total) 0.1Chloramines 0.1Chloride 50Chromium 0.014Copper 0.1Fluoride 0.2 0.2FormaldehydeMagnesium 2 4Mercury 0.001 0.0002Nitrate 2 2Lead 0.1 0.005Potassium 2 8Selenium 0.09Silver 0.005Sodium 50 70Sulfate 50 100Tallium 0.002Zinc 0.1 0.1

L. The key elements to be considered for choosing the most appropriate components to include in the water system are the feed water contamination levels and the maximum allowed or wished-for levels of contaminants in the final product water.

M. Constantly moving water is considered an essential factor to avoid bacterial growth; therefore a close loop distribution system represents the optimum design.

N. Material used for piping has to offer smooth surfaces and good resistance to the disinfection procedure and to the release of chemicals or particles.

O. Polyvinyl chloride (PVC) has been the most used piping material. However, the AISI 316L stainless steel, cross-linked polyethylene (PEX) or polyvinylidene fluoride (PVDF) offer more advantages and are increasingly used.

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4. Machines:A. Machines should be considered for replacement after seven years

of service or after completing 50,000 hours operation, whichever is first.

B. The basic specifications of the dialysis machines: should include the following:

1. The capability of performing bicarbonate hemodialysis and bicarbonate variation. Also be able to accept bicarbonate as a powder cartrdige.

2. Automatic control of ultra filtration of fluid ranging from zero to 2000ml/hour with an ability of performing isolated ultrafiltration. Preferably to have volumetric control of ultrafiltration.

3. Built-in heparin pump.4. Electronically operated temperature control of dialysate in the

machine and integrated thermometer with range from 31-42 degrees centigrade.

5. Built-in roller blood pump with a flow range of blood from zero to at least 400 ml/min with a readable indicator of flow rate. The pump should allow manual operation in case of power failure.

6. Built-in air detection device in venous blood, integrated with clamp for venous line, which shuts off automatically upon detection of any air bubble or excessive foam.

7. Built-in blood leak detection unit into the dialysate.8. The capability for variation of sodium concentration in the

dialysate.9. Built-in venous and arterial blood pressure sensors with an

indicator for both pressures.10. Built-in conductivity meter with an indicator.11. Built-in dialysate flow meter.12. The indicators of the operational status of the different

parameters should be clearly displayed on the machine.13. The machine should be a micro processor controlled unit.14. Built-in facility for standard automatic disinfection procedures.

Facility for chemical disinfection is a must.15. To comply with the international electric compatibility (I.E.C).

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16. All alarm systems must be of audiovisual type for the following:

16.1 Power failure.16.2 Change of pressure of venous and arterial lines.16.3 Air bubbles in blood.16.4 Blood leak into dialysate.16.5 Temperature change of the dialysate.16.6 Change in conductivity of the dialysate.

17. Optional devices in the hemodialysis machine may include:17.1 Ability to display the operational status of the dialysis

machine, parameters, and instructions to the operator of the machine on an electronic screen.

17.2 Capability to perform hemo-filtration mode of therapy.17.3 Ability for monitoring of the patient blood pressure

continuously, while the patient is on dialysis.17.4 To have expanded memory for stored data about the

patients conditions.17.5 Capability for programmable ultrafiltration profiling.17.6 Capability to have profiling of sodium in the dialysis

(programming).17.7 Preferably to have blood temperature profiling module.17.8 Preferably to have a module to measure vascular access

recirculation and/or access blood flow.17.9 Preferably to have capacity for on-line production of

hemodia-filtrate for hemodia-filtration mode.17.10Preferably to have on-line blood volume monitor (Crit-on-

line).17.11Preferably to have on-line clearance monitor depending on

conductivity of sodium or urea sensoring.17.12Preferably to have ability to measure Hemoglobin of the

patient during the dialysis.17.13Preferably to be able to measure/calculate KT/V of the

patient.18. Hemodialysis machines that can perform single needle dialysis

should be available in a ratio not more than 5% in any dialysis unit and as an emergency measure for dialysis.

19. The basic specifications for dialysis chairs for patients should 18

include the following:19.1 The chair should be manufactured of a rust proof material

which is easy to clean and sterilize. There should be attached cushion.

19.2 The width should range between 55 and 70cm.19.3 It must be both electrically and manually operable.19.4 There should be a provision to make it flat like a bed.19.5 Head and foot segments of the chair must be movable both

together and independently.19.6 There should be provision to adjust the height of the chair.19.7 The arm rests must be movable both horizontally and

vertically.19.8 There should be provision to palace a patient in the

trendelebergh position while using the chair.19.9 To have 110-220 voltage and 60 Hz driving motor and if

unavailable to be able to match the electricity of the dialyser center.

5. Dialyzer MembranesA. Dialyzer membranes with the lowest degree of complement and

leukocyte activation should be applied. Dialyzer membranes that induce strong complement and leukocyte activation, inflammatory reactions, and/or a blunting of the response of leukocytes to stimuli should be avoided.

B. Differences in thrombogenicity should be considered in the choice of the dialyzer

C. In order to prevent the release of fragments (solid or soluble) from the dialyzer circuit, and their accumulation in several organs of the body, adequate dialyzer pre-rinsing according to the manufacturers instructions should be performed. If no manufacturer instructions are given, the dialyzers should be pre-rinsed using at least 2 L of rinsing solution. Over-occlusion of the roller pumps should be avoided as well.

D. Careful consideration should be given to the use of high-flux membranes for patients expecting prolonged dialysis (> 5 years).

E. Use of dialyzers and tubings sterilized with EtO should be avoided, especially in patients showing otherwise unexplained signs of 19

anaphylactoid reaction, eosinophilia or elevated IgE. Sterilization by steam or γ radition is becoming more popular.

F. Reuse of dialysers should not be practiced due to its many disadvantages.

G. The combination of dialysis with AN69 membranes and medical treatment with ACE-inhibitors (ACE-i) should be avoided because of the possibility of severe hemodynamic reactions.

H. Shear stress-related problems of hemolysis can be prevented by:1. The use of large fistula needles/cannulae of 15-16 gauges.2. The application of an optimal relationship between dialyzer

blood flow and access diameter.3. The prevention of highly negative arterial pressure alarms

(exceeding 150 mmHg).4. The correct positioning of cannulae and needles in the access

system.5. The correct positioning of tubings in the roller pumps.6. Minimizing recirculation.7. The maintenance of vascular access systems in anatomically

correct condition.

6. Dialysate propertiesA. The dialysate should contain bicarbonate as the buffer.B. Bicarbonate concentrate must be handled with care to prevent

bacterial contamination after container opening. The use of already opened containers should be discouraged.

C. Ready for use powder cartridges are the prefered method to deliver bicardonate during dialysis than the prepared batch of dissolved bicarbonate.

D. Hypoglycemia is not seen if the dialysate contains glucose, but glucose-containing dialysate is slightly more expensive.

7. Anticoagulants Use in HemodialysisA. No clear differences in hemodialysis (LMWHs) adequacy results

have been demonstrated using standard unfractionated heparin and LMWHs.

B. No differences in dialysis adequacy results are achieved using 20

different LMWHs. C. There is no clear difference in the risk of thrombosis or

hemorrhage with LMWHs compared with standard heparins, although the results of individual studies have been quite variable.

D. LMWHs have been suggested to have a number of other potential benefits with regard to bleeding risk, anticoagulant efficacy, risk of heparin-induced-thrombocytopaenia and lipid profile. These benefits remain unproven in patients on dialysis, with inconclusive and sometimes conflicting data available from randomized controlled trials

E. LMWHs are simpler and more convenient to use given their once-only bolus method of administration; this may be an important consideration for some centres and some groups of patients.

F. This convenience of LMWHs is balanced by the substantially higher cost of these agents compared with unfractionated heparin. Until more data directly comparing the two becomes available, individual units should make a decision based on whether the extra cost can be justified by the issues of convenience.

G. LMWHs have a limited duration of action, so a single bolus injection may not provide adequate anticoagulation for long dialysis sessions (e.g. overnight dialysis).

IV. Vascular Access for Hemodialysis

1. Vascular Access PlacementA. To determine the type of access most suitable for an ESRD patient,

a history must be taken and physical examination of the patient's 21

venous, arterial, and cardiopulmonary systems must be performed. Diagnostic evaluation should be performed when indicated based on patient history or physical examination.

B. Venography prior to placement of access is indicated in patients with the following:

1. Edema in the extremity in which an access site is planned. 2. Collateral vein development in any planned access site. 3. Differential extremity size, if that extremity is contemplated as

an access site. 4. Current or previous subclavian catheter placement of any type

in venous drainage of planned access. 5. Current or previous transvenous pacemaker in venous drainage

of planned access. 6. Previous arm, neck, or chest trauma or surgery in venous

drainage of planned access.7. Multiple previous accesses in an extremity planned as an access

site. C. Additional or alternate imaging techniques are indicated in

selected cases where multiple previous vascular accesses have been placed, or when residual kidney function makes contrast studies undesirable. Appropriate techniques include:

1.Doppler ultrasound. 2.Magnetic resonance imaging.

D. Arteriography or Doppler examination is indicated when arterial pulses in the desired access location are markedly diminished.

E. The order of preference for placement of AV fistulae in patients with kidney failure who will become hemodialysis dependent is:

1.A wrist (radial-cephalic) primary AV fistula. 2.An elbow (brachial-cephalic) primary AV fistula.

F. If a primary AV fistula cannot be established, a synthetic AV graft is the next preferred type of vascular access.

1. Polytetrafluoroethylene (PTFE) tubes are preferred over other synthetic materials.

2. There is no convincing evidence to support tapered over uniform tubes, externally supported over unsupported grafts, thick- versus thin-walled configurations, or elastic versus nonelastic material.

22

3. Grafts may be placed in straight, looped, or curved configurations. Designs that provide the most surface area for cannulation are preferred.

4. Location of graft placement is determined by each patient's unique anatomical restrictions, the surgeon's skill, and the anticipated duration of dialysis.

G. Tunneled cuffed venous catheters are the method of choice for temporary access of longer than 3 weeks' duration. They also are acceptable for access of shorter duration.The indications for tunneled catheters include:

1. Some patients who have exhausted all other access options2. Patients who have a primary AV fistula maturing but need

immediate hemodialysis. H. The preferred insertion site for tunneled cuffed venous dialysis

catheters is the right internal jugular vein. Other options include: the right external jugular vein, the left internal and external jugular veins, subclavian veins, femoral veins, or trans- lumbar access to the inferior vena cava.

1.Subclavian access for tunneled cuffed venous dialysis catheters should be used only when jugular options are not available. 2.Tunneled cuffed catheters should not be placed on the same side as a maturing AV access, if possible. 3.Fluoroscopy or real-time ultrasound-guided insertion is mandatory for insertion of all cuffed dialysis catheters. The catheter tip should be adjusted to the level of the caval atrial junction or into the right atrium to ensure optimal blood flow. Atrial positioning is only recommended for catheters composed of soft compliant material, such as silicone.

I. There is currently no proven advantage of one cuffed catheter design over another. Catheters capable of a rapid blood flow rate are preferred. Catheter choice should be based on local experience, goals for use, and cost.

J. Hemodialysis access of less than 3 weeks' duration should be obtained using a non- cuffed, or a cuffed, double-lumen percutaneously inserted catheter:

1.These catheters are suitable for immediate use and should not be inserted before needed. 23

2.Noncuffed catheters can be inserted at the bedside in the femoral, internal jugular, or subclavian position. 3.The subclavian insertion site should not be used in a patient who may need permanent vascular access due to the risk of central venous stenosis.4.Chest x-ray is mandatory after subclavian and internal jugular insertion prior to catheter use to confirm catheter tip position at the caval atrial junction or the superior vena cava and to exclude complications prior to starting hemodialysis. 5.Where available, ultrasound should be used to direct insertion of these catheters into the internal jugular position to minimize insertion-related complications. 6.Femoral catheters should be at least 19-cm long to minimize recirculation. Noncuffed femoral catheters should not be left in place longer than 5 days and should be left in place only in bed-bound patients. 7.Nonfunctional noncuffed catheters can be exchanged over a guidewire or treated with urokinase or tissue plasminogen factor as long as the exit site and tunnel are not infected. 8.Exit site, tunnel tract, or systemic infections should prompt the removal of noncuffed catheters.

K. Arm veins suitable for placement of vascular access should be preserved, regardless of arm dominance.

1.Arm veins, particularly the cephalic veins of the nondominant arm, should not be used for venipuncture or intravenous catheters. 2.The dorsum of the hand should be used for intravenous lines in patients with chronic kidney disease. When venipuncture of the arm veins is necessary, sites should be rotated.3.Instruct hospital staff, patients with progressive kidney disease (creatinine >300 µmol/L), and all patients with conditions likely to lead to ESRD to protect the arms from venipuncture and intravenous catheters. 4.An alert bracelet may be worn to inform hospital staff to avoid IV cannulation of essential veins.

L. Patients with chronic kidney disease should be referred for surgery to attempt construction of a primary AV fistula when their creatinine clearance is <25 mL/min (stage 4 CKD).

24

1.The patient should be referred to a nephrologist prior to the need for access to facilitate kidney failure treatment and for counseling about modes of ESRD care, including hemodialysis, peritoneal dialysis, and renal transplantation. 2. A new primary fistula should be allowed to mature for at least 1 month, and ideally for 3 to 4 months, prior to cannulation.3. Dialysis AV grafts should be placed at least 3 to 6 weeks prior to an anticipated need for hemodialysis in patients who are not candidates for primary AV fistulae.4.Hemodialysis catheters should not be inserted until hemodialysis is needed.5.A primary AV fistula is mature and suitable for use when the vein's diameter is sufficient to allow successful cannulation, but not sooner than 1 month (and preferably 3 to 4 months after construction.

M. Maturation of AV fistulae can be enhanced by:1.Fistula hand-arm exercise (eg, squeezing a rubber ball with or without a lightly applied tourniquet) will increase blood flow and speed maturation of a new native AV fistula.2.Selective obliteration of major venous side branches will speed maturation of a slowly maturing AV fistula.3.When a new native AV fistula is infiltrated (ie. presence of hematoma with associated induration and edema), it should be rested until swelling is resolved.

N. PTFE dialysis AV grafts should not routinely be used until 14 days after placement.

1.Cannulation of a new PTFE dialysis AV graft should not routinely be attempted, even 14 days or longer after placement, until swelling has gone down enough to allow palpation of the course of the graft. Ideally, 3 to 6 weeks should be allowed prior to cannulation of a new graft. 2.Erythema of a new dialysis AV graft should not prevent its use, as long as the redness is limited to the path of the graft. Erythema along the path of the graft suggests surgical inflammation rather than infection.3. Patients with swelling that does not respond to arm elevation or that persists beyond 2 weeks after dialysis AV access placement

25

should receive a venogram or other noncontrast study to evaluate central veins.

O. Cuffed and noncuffed hemodialysis catheters are suitable for immediate use and do not require maturation time.

2. Monitoring, Surveillance, and Diagnostic TestingA. Monitoring refers to the examination and evaluation of the

vascular access by means of physical examination to detect physical signs that would suggest the presence of pathology.

B. Physical examination of an access graft should be performed weekly and should include, but not be limited to, inspection and palpation for pulse and thrill at the arterial, and venous sections of the graft.

C. Data from the clinical assessment and dialysis adequacy measurements should be collected and maintained for each patient's access and made available to all staff. The data should be tabulated and tracked within each dialysis.

D. Surveillance refers to periodic evaluation of the vascular access by means of tests that may involve special instrumentation, for which an abnormal test result suggests the presence of pathology.

E. Diagnostic Testing refers to testing that is prompted by some abnormality or other medical indication, and which is undertaken to diagnose the presence of pathology.

F. Access flow measured by ultrasound dilution, conductance dilution, thermal dilution, Doppler or other technique should be performed monthly.

1.The assessment of flow should be performed during the first 1.5 hours of the dialysis session to eliminate error caused by decreases in cardiac output related to ultrafiltration. 2.The mean value of 3 separate determinations performed at a single treatment should be considered the access flow.

G. AV graft and AV fistula access flow less than 600 mL/min, the patient should be referred for fistulogram.

H. Access Flow less than 1,000 mL/min that has decreased by more than 25% over 4 months should be referred for fistulogram.

I. Prospective surveillance of AV grafts for hemodynamically significant stenosis, when combined with correction, improves

26

patency and decreases the incidence of thrombosis. Techniques, not mutually exclusive that can be used in surveillance for stenosis in AV grafts include, in order of decreasing preference:

1.Intra-access flow.2.Static venous dialysis pressure. 3. Dynamic venous pressures.4. Measurement of access recirculation using urea concentrations. 5.Measurement of recirculation using dilution techniques (non-urea-based). 6. Unexplained decreases in the measured amount of hemodialysis delivered.7. Physical findings of persistent swelling of the arm, clotting of the graft, prolonged bleeding after needle withdrawal, or altered characteristics of pulse or thrill in a graft.8.Elevated negative arterial pre-pump pressures that prevent increasing to acceptable blood flow.9.Doppler ultrasound,

J. Persistent abnormalities diagnostic testing in AV grafts in any of these parameters should prompt referral for venography.

K. All patients should be taught how to:1.Compress a bleeding access.2.Seal the site of a central venous catheter (CVC) with ointment to keep air embolus from entering.3.Wash skin over access with soap and water daily and before dialysis.4.Recognize signs and symptoms of infection.5.Select proper methods for exercising AV fistula arm with some resistance to venous flow.6.Palpate for thrill/pulse daily and after any episodes of hypotension, dizziness, or lightheadedness.7.Listen for bruit with ear opposite access if cannot palpate for any reason,8.Avoid carrying heavy items draped over the access arm or wearing occlusive clothing.9.Avoid sleeping on the access arm.10. Insist that staff rotate cannulation sites daily.11. Insure that all staff use proper techniques in preparing skin prior

27

to cannulation.12. Report any signs and symptoms of infection or absence of bruit/thrill to dialysis personnel immediately.

L. Intervention with percutaneous transluminal angioplasty (PTA) or surgical revision to correct stenoses dramatically reduces the rate of AV graft thrombosis and loss.

M. Sequential timely repetitive measurement of access flow is the preferred method for surveillance of AV grafts.

N. Doppler flow, ultrasound dilution, and magnetic resonance have been the most extensively evaluated. All require specialized devices and some are expensive such as the magnetic resonance.

O. Although Doppler studies can be predictive of access stenosis and the likelihood for failure, inter-observer variability in measurement of Doppler can reduce the reliability of Doppler flow measurement. Variation in Doppler flow measurements performed by machines produced by different manufacturers also occurs.

P. Both Doppler flow and magnetic resonance are difficult to perform during dialysis sessions. In contrast, flow measurements performed by ultrasound velocity and other techniques using blood dilution are reliable and valid and can be done on-line during dialysis, thereby providing rapid feedback.

Q. Trends in either dynamic or static venous dialysis pressure measurements are more predictive of access stenosis than any single pressure measurement.

R. Unexplained decreases in delivered dialysis dose, as measured by Kt/V or URR, are frequently associated with venous outflow stenoses. However, many other factors influence Kt/V and URR, making them less sensitive and less specific for detecting access dysfunction.

S. Recirculation should be measured using a nonurea-based dilutional method or by using the two-needle urea-based method.

T. The three-needle peripheral vein method of measuring recircula-tion should not be used.

U. Any access recirculation is abnormal. Recirculation exceeding 10% using the recommended two-needle urea-based method, or 5% using a nonurea-based dilutional method, should prompt investigation of its cause.

28

V. If access recirculation values exceed 20%, correct placement of needles should be confirmed before conducting further studies.

W. Elevated levels of access recirculation should be investigated using angiography (fistulography) to determine whether stenotic lesions are impairing access blood flow.

3. Prevention of Infection Staff and patient education should include instruction on infection control measures for all hemodialysis access sites.A. All dialysis staff should be trained in infection control procedures. B. Documenting educational materials and objectives must be part of

the patient's records and staff orientation records in terms of catheter care and accessing the patient's circulation.

C. Tracking the occurrence of infections can help identify the source and allow corrective action to be taken. Ongoing quality assurance, risk management, or CQI efforts should be in place to monitor the incidence of infection, to evaluate the response to patient and staff education, and to identify future educational needs.

D. A clean technique for needle cannulation should be used for all cannulation procedures.

1.Locate and palpate the needle cannulation sites prior to skin preparation.2.Wash access site using an antibacterial soap or scrub (eg, 2% chlorhexidine) and water.3.Cleanse the skin by applying 70% alcohol and/or 10% povidone iodine using a circular rubbing motion.4.Alcohol has a short bacteriostatic action time and should be applied in a rubbing motion for 1 minute immediately prior to needle cannulation.5.Povidone iodine needs to be applied for 2 to 3 minutes for its full bacteriostatic action to take effect and must be allowed to dry prior to needle cannulation.6.Clean gloves should be worn by the dialysis staff for cannulation. Gloves should be changed if contaminated at any time during the cannulation procedure.7.New, clean gloves should be worn by the dialysis staff for each patient.

29

8.After skin preparation, skin should be pulled tight in opposite direction of needle insertion.9.Approximately 45 degree angle of insertion should be used for AV graft and approximately 25 degree angle for AV fistula.10.Once the vessel has been penetrated, there are basically three methods employed in practice:

10.1 Advance the needle slowly with cutting edge facing top of vessel and do not rotate axis.

10.2 Immediately rotate the axis of the needle 180 degrees and advance slowly with cutting edge facing bottom of the vessel.

10.3 Advance the needle to desired position, and then rotate the axis 180 degrees.

11.Tape the needle at the same angle or one similar to the angle of insertion.12.Remove needle at same or angle similar to angle of insertion, and never apply pressure before the needle is completely out.

F. For catheter care and accessing the patient's circulation should be clean procedures.

1.Hemodialysis catheter dressing changes and catheter manipulations that access the patient's bloodstream should only be performed by trained dialysis staff. 2.The catheter exit site should be examined at each hemodialysis treatment for signs of infection. 3. Catheter exit site dressings should be changed at each hemodialysis treatment.4. Use of dry gauze dressing combined with skin disinfection, using either chlorhexidine or povidone iodine solution, followed by povidone iodine ointment or mupirocin ointment at the catheter exit site are recommended after catheter placement and at the end of each dialysis session.5. Manipulating a catheter and accessing the patient's bloodstream should be performed in a manner that minimizes contamination.6. During catheter connect and disconnect procedures, nurses and patients should wear a surgical mask or face shield. Nurses should wear gloves during all connect and disconnect procedures. Also these precautions should be adopted for all catheter dressing

30

changes.7.The catheter hub caps or blood line connectors should be soaked for 3 to 5 minutes in povidone iodine and then allowed to dry prior to separation, or to use new hub caps.8.Catheter lumens should be kept sterile.To prevent contamination, lumens and tips should never remain open to air. A cap or syringe should be placed on or within the catheter lumen, while maintaining a clean field under the catheter connectors.9.In patients with an allergy to povidone iodine, alternate agents such as polyan-tiraicrobial gel can be substituted. Catheter infection can occur following transmission of hand or aerosolized bacterial contaminants. 10. Staphylococcus aureus is the leading cause of catheter exit site infection and bacteremia in hemodialysis patients. Bacteremia and tunnel tract infections are the leading causes of catheter loss.11. Chronic hemodialysis patients are at increased risk of S aureus nasal carriage (a 50% to 60% carriage rate in hemodialysis patients).12. Nasal carriage may result in seeding the skin with autogenous S aureus, leading to catheter site infection, tunnel track infection, or bacteremia. 13.Catheter placement near the patient's nose and mouth, such as occurs with subclavian or jugular vein catheters, exposes the patient's catheter exit site to nasal drainage/discharge and infectious airborne droplets.

13.1 Methicillin-resistant S aureus may be transmitted in this mode.

13.2 A surgical mask worn by the patient and nurse any time the catheter is accessed reduces the spread of infectious droplets and reduces contamination of the catheter site.

G. Local infection of a dialysis AV graft should be treated with appropriate antibiotics based on culture results and by incision/resection of the infected portion of the graft.

1.Extensive infection of a dialysis AV graft should be treated with antibiotics and total resection of the graft. 2.Infection of a newly placed graft (ie, within 1 month) should be treated with antibiotics and by removing the graft, regardless of the

31

extent of the infection. 3.Initial antibiotic treatment should cover both Gram-negative and Gram-positive organisms and should cover Enterococcus species.

H. Infections of primary AV fistulae are rare and should be treated as subacute bacterial endocarditis with 6 weeks of antibiotic therapy. Though septic emboli are rare, they call for taking the fistula down.

I. Tunneled cuffed catheter infection is a serious problem. Appropriate treatment is dependent upon the nature of the infection:

J. Catheter exit site infections characterized by redness, crusting, and exudate at the exit site in the absence of systemic symptoms and negative blood cultures should be treated as follows:

K. Apply topical antibiotics, ensuring proper local exit site care; do not remove the catheter.

L. If there is tunnel drainage, parenteral antibiotics (anti-staphylococcal, anti-streptococcal therapy should be initiated pending exit site cultures) in addition to following appropriate local measures. Definitive therapy should be based on culture results. The catheter should not be removed unless the infection fails to respond to therapy.

M. If the infection fails to respond to therapy, the catheter should be removed and replaced by using a different tunnel and exit site.

N. Catheter-related bacteremia, with or without systemic signs or symptoms of illness, should be treated by initiating parenteral treatment with an antibiotic(s) appropriate for the organism(s) suspected, usually Staphylococcus and Streptococcus.

O. Definitive therapy should be based on the organism(s) isolated. The catheter should be removed in all instances if the patient remains symptomatic more than 36 hours. The catheter should also be removed in any clinically unstable patient.

P. Antibiotic bloc (filling antibiotic in the catheter lumen) after dialysis session should be applied to control the systemic infection.

Q. A new permanent access should not be placed until blood cultures, performed after cessation of antibiotic treatment, have been negative for at least 48 hours.32

4. Management of Complications: Stenosis, Thrombosis, and Aneurysm A. All patients, particularly those in high-risk groups, should be

monitored for the development of limb ischemia following AV access construction.

B. Patients in high-risk groups (diabetic, elderly, those with multiple access attempts in an extremity) should be monitored closely for the first 24 hours postoperatively. Monitoring should include:

1. Subjective assessment of complaints, including sensations of coldness, numbness, tingling, and impairment of motor function (not limited by postoperative pain).

2. Objective assessment of skin temperature and gross sensation, and movement in addition to distal arterial pulses in comparison to the contralateral side.

3. Teaching patients to immediately report any coldness, loss of motion, or significant reduction in sensation.

4. Patients with an established fistula should be assessed monthly. The following are recommended as part of this assessment.

4.1 Obtaining an interval history of increased distal coldness or distal pain during dialysis, decreased sensation, weakness or other reduction in function, or skin changes.

4.2 Confirming any abnormalities by physical examination.C. Appropriate intervention in AV grafts should be initiated upon

identification of:1.Hemodynamically significant stenosis.2.Infection. An infected graft should be treated surgically. 3. Graft degeneration and pseudoaneurysm formation. Grafts should be surgically revised when:

3.1 Severe degenerative changes of the graft or overlying skin are present.

3.2 Skin above the graft is compromised. 3.3 There is a risk of graft rupture due to poor eschar formation

or there is evidence of spontaneous bleeding. 3.4 Limited puncture sites are available due to the presence of

a large or multiple pseudoaneurysm(s).D. Appropriate intervention in primary AV fistulae should be initiated

upon identification of:33

1.Inadequate flow to support the prescribed dialysis blood flow. 2.Hemodynamically significant venous stenosis. 3.Aneurysm formation. A primary AV fistula should be revised when an aneurysm develops if:

3.1 The skin overlying the fistula is compromised.3.2 There is a risk of fistula rupture.3.3 Available puncture sites are limited.

E. Stenoses that occur in a dialysis AV graft or primary AV fistula (venous outflow or arterial inflow) should be treated with percutaneous transluminal angioplasty or surgical revision if the stenosis is >50% of the lumen diameter and is associated with the following abnormalities:

1.Previous thrombosis in the access.2.Elevated venous dialysis pressure.3.Abnormal urea or other recirculation measurements.4.Abnormal physical findings. 5.Unexplained decrease in measure-ment of dialysis dose.6.Decreasing access flow.

F. Each dialysis center should determine which procedure (angioplasty versus surgical revision) is best for the patient based on the expertise at that center.

G. Stenosis, as well as the clinical parameters used to detect it, should return to within acceptable limits following intervention.

H. Centers should monitor stenosis treatment outcomes on the basis of patency; reasonable patency goals (for the center as a whole) for PTA and surgical revision in the absence of thrombosis are:

I. PTA: 50% unassisted patency at 6 months; no more than 30% residual stenosis post procedure, and resolution of physical indicators of stenosis.

1.Surgical revision: 50% unassisted patency at one year.J. If angioplasty is required more than 2 times within 3 months, the

patient should be referred for surgical revision if such an option is available and if the patient is a good surgical candidate.

K. Stents are useful in selected instances (eg, limited residual access sites, surgically inaccessible lesions, contraindication to surgery or when PTA fails.

L. Percutaneous intervention with transluminal angioplasty is the

34

preferred treatment for central vein stenosis.M. Stent placement combined with angioplasty is indicated in elastic

central vein stenoses or if a stenosis recurs within a 3-month period.

N. Thrombosis of an AV graft should be corrected with surgical thrombectomy or with pharmacomechanical or mechanical thrombolysis. The choice of technique to treat thrombosis should be based on the expertise of the center. However, it is essential that:

1. Treatment is performed rapidly following detection of thrombosis to minimize the need for temporary access.

2. The access is evaluated by Dopoler ultrasound. 3. Residual stenosis is corrected by angioplasty or surgical

correction.4. The procedure is performed as outpatient procedure under local

anesthesia. Access revision may require up to a 24-hour obser-vation to evaluate swelling and steal.

5. Monitoring tests used to screen for venous obstruction should return to normal following intervention.

O. Thrombosis of an AV fistula is difficult to treat. Neither percutaneous nor surgical techniques offer good results. Each institution should attempt to resolve thrombosis with the technique that is preferred at that institution.

P. Catheter dysfunction is defined as failure to attain and maintain an extracorporeal blood flow sufficient to perform hemodialysis without significantly lengthening the hemodialysis treatment. Sufficient extracorporeal blood flow is around 300 mL/min.

R. Tissue plasminogen activator (TPA) and recombinant urokinase (rUK) may be used to treat thromboed catheters. If they fail, the thrombosed catheter should be changed over a guidewire.

S. Intra-catheter urokinase infusion (eg, 20.000 units/lumen/hour) for 6 hours if a fibrin sheath is present or a luminal thrombosis remains.

T. Better approach is to use TPA 2mg/2ml to fill the catheter.The dwell time is 2 hours. Successful recanalization should be if blood flow is more than 200 ml/min. The dose can be repeated if needed.

U. Needle insertion into the area of pseudoaneurysm should be

35

avoided. Pseudoaneurysm of a dialysis AV graft should be treated by resection and insertion of an interposition graft if the pseudoaneurysm:

1. Is characterized by rapid expansion in size. 2. Exceeds twice the diameter of the graft. 3. Threatens viability of the overlying skin. 4. Is infected.

V. Aneurysms of primary AV fistulae require surgical intervention only when the aneurysm involves the arterial anastomosis. Venipuncture should avoid the aneurysm.

W. Dialysis centers should:1.Institute monitoring programs to detect vascular accesses at risk.2.Establish quality assurance programs that track access complication rates and outcomes.3.Develop methods that extend access use-life by:

3.1 Increasing the percentage of patients with native or primary AV fistulae.

3.2 Early identification and referral of patients with progressive kidney disease to nephrologists, allowing access construction well in advance of the need for hemodialysis.

3.3 Reevaluation for a native AV fistula after every access failure.

3.4 Periodic monitoring of accesses to detect hemodynamically significant stenoses prior to thrombosis.

3.5 Expeditious referral of patients for appropriate angioplasty or surgical revision following the detection of stenoses.

3.6 Implementing staff and patient education programs on the importance and care of vascular access.

3.7 Primary AV fistulae should be constructed in at least 50% of all new kidney failure patients electing to receive hemodialysis as their initial form of renal replacement therapy. Ultimately, 40% of prevalent patients should have a native AV fistula.

3.8 Patients should be re-evaluated for possible construction of a primary AV fistula after failure of every dialysis AV access.

3.9 Each center should establish a database to track the types of

36

accesses created and the complication rates. 4. Less than 10% of chronic maintenance hemodialysis patients should be maintained on catheters as their permanent chronic dialysis access. In this context, chronic catheter access is defined as the use of a dialysis catheter for more than 3 months in the absence of a maturing permanent access. 5. ESRD patients should be educated on the risks and benefits associated with catheters and strongly encouraged to allow the creation of an AV fistula for permanent access where appropriate. 6.The rate of graft thrombosis should not exceed 0.5 thrombotic episodes per patient year at risk. 7. After adjusting for initial failures (ie, failures within the first 2 months of fistula use), the rate of thrombosis of native AV fistulae should be less than 0.25 episodes per patient year at risk. 8. Dialysis centers should examine their thrombosis rates and the underlying causes as part of an ongoing quality care program.9.The rate of infection should not exceed 1 % in primary AV fistulae and should not exceed 10% in dialysis AV grafts, both calculated over the use-life of the access. 10.For tunneled cuffed catheters, the recommended target rate of systemic infection is less than 10% at 3 months and less than 50% at 1 year. 11.The primary access failure rates of virgin dialysis AV grafts in the following locations and configurations should not be more than:

11.1 Forearm straight grafts:15%11.2 loop grafts: 10%11.3 Upper arm grafts: 5%

12.The creation and maintenance of access sites as distally as possible is encouraged to preserve more proximal veins for future access options.13.Each center should monitor its performance to identify problems in access construction and use. 14.The primary failure rate of tunneled cuffed catheters should be no more than 5%. The cumulative incidence of the following insertion complications should not exceed 2% of all catheter placements:

14.1 Pneumothorax requiring a chest tube.37

14.2 Symptomatic air embolism.14.3 Hemothorax.14.4 Hemomediastinum.14.5 Hematoma requiring evacuation.

15.The cumulative patency rate of dialysis AV grafts ( the number of grafts that remain patent regardless of the number of primary interventions and/or thrombectomies during the given time period) should be at least 70% at 1 year, 60% at 2 years, and 50% at 3 years.

38

V. Adequacy of Hemodialysis

1. Regular Measurement of the Delivered Dose of Hemodialysis

A. The dialysis care team should routinely measure and monitor the

delivered dose of hemodialysis. B. All patients receiving hemodialysis in the same dialysis facility

should have the delivered dose of hemodialysis measured using the same method.

C. The delivered dose of hemodialysis in adult and pediatric patients should be measured using formal urea kinetic modeling, employing the single-pool, variable volume model.

D. The measurement of the delivered dose of hemodialysis includes:1.The availability of dialysis unit staff to properly collect blood samples and record information from the dialysis session, such as the type of dialyzer used, intradialytic weight loss, blood and dialysate flows, true dialysis time, etc; and the time to record, enters, and processes this information.2.Urea is the substance that is most often monitored in clinical practice as a surrogate for measurement of the clearance of small solutes in general.3.The dialysate collection method is an alternative approach for quantifying the delivered hemodialysis dose. This method has been considered to be the gold standard for urea kinetic analysis, but not routinely available, and impractical to implement in most hemodialysis units.4.To normalize for differences in the size and habitus of patients, a dose of hemodialysis (prescribed or delivered) is best described as the fractional clearance of urea as a function of its distribution volume (Kt/V). The fractional clearance is operationally defined as the product of K (dialyzer clearance measured in liters per minute [L/min]), the t (treatment time) and V (volume of distribution of urea measured in L).5.Kt/V may be determined by formal urea kinetic modeling (UKM) or by extrapolation from the fractional change in blood urea concentration (URR) during a dialysis session.

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6.URR = 100 X (1 - Ct/Co) in which Ct is the postdialysis BUN and Co is the predialysis BUN.7.Formal urea kinetic modeling (UKM) is the most rigorous method for prescribing dialysis treatment and evaluating the consistency with which the prescribed treatment is delivered to the patient. UKM requires accurate measurement of:

7.1.Predialysis and postdialysis BUN for the first dialysis treatment of the week and the predialysis BUN for the second dialysis session of the week in a thrice-weekly hemodialysis schedule.7.2.Predialysis and postdialysis weights at the time of the first hemodialysis treatment of the week.7.3.The actual treatment time (the exact number of minutes during which the hemodialysis treatment was delivered on the first dialysis treatment of the week). 7.4.The effective clearance of the dialyzer as measured in the hemodialysis unit (not the in vitro clearance value reported by the manufacturer alone).

8.Formal UKM provides a mechanism to check for errors in the delivered dose of hemodialysis. 9.A discrepancy between the kinetically derived V and the V expected from anthropometric calculations is an indicator of potential technical problems with the hemodialysis session. such as:

9.1.Blood flow from the vascular access.9.2.The performance of the dialyzer. 9.3. The dialysate flow during the hemodialysis treatment.9.4.The dialysis machine programming. 9.5.The hemodialysis treatment time.9.6.The predialysis BUN sampling.

10.The disadvantages of formal UKM are logistical:10.1.The complexity of the calculations requires the use of computational devices and software.10.2.Physical parameters, such as the K and V, are difficult to measure and to monitor, 10.3.The actual treatment time can be difficult to determine.10.4.The time required for the dialysis unit staff to accurately collect and adequately process all patient information to support

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these calculations can be significant in large dialysis units. 11. KT/V derived from URR needs to be adjusted to the level of ultrafiltration. URR does not measure the residual renal function. However, it is the most practical method at bed side.

E. Double pool Model1.During the course of a hemodialysis session, flow-volume disequilibrium for urea between vascular beds results in the preferential loss of urea from the well-perfused, but relatively urea-depleted vascular beds. This compartmentalization of urea results in rebound in the BUN concentration over the 15-60 minutes after the completion of hemodialysis.2.The double-pool, variable-volume urea kinetic model may more accurately quantify intradialytic urea removal and may result in a more precise normalized protein catabolic rate (NPCR) because of the more accurate assessment of V (in comparison to an anthropometric value) 3.The need to obtain the postdialysis BUN sample 30 to 60 minutes after the completion of hemodialysis (equilibrated postdialysis BUN sample) can be overcome by the following formula depending upon the location of the vascular access and the site from which the postdialysis BUN sample was obtained. Kt/Vsp. calculated using an arterial postdialysis BUN sample from an arteriovenous vascular access (art Kt/V), will be greater than that calculated from a mixed venous postdialysis BUN, drawn through a venovenous vascular access (ven Kt/V).

3.1.The corresponding equilibrated eKt/V values are calculated by:

Arterial Kt/V equilibrated = art Kt/Vsp- (0.6 X art Kt/Vsp/T) + 0.03Venous Kt/V equilibrated = ven Kt/Vsp - (0.47 X ven Kt/Vsp/T) + 0.02 in which T is the dialysis treatment time in hours , t is the dialysis time in minutes and sp is single pool .

3.2.This approach is based on the observation that the 30-minute postdialysis BUN concentration is not statistically different from the intradialytic concentration 30 minutes before the end of hemodialysis.

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3.3.Using the formula for calculating Kt/Vequil, the impact of the duration of hemodialysis on the single-pool is included. 3.4.The use of Kt/Vequil is considerably easy to reflect the two-compartment urea kinetic model and calculate the delivered dose of hemodialysis. It is a useful adjunct to a complete kinetic modeling program.

2. Dialysis Dose

A. The dialysis care team should deliver a Kt/V of at least 1.2 (single-pool, variable volume) for both adult and pediatric hemdialysis patients. For those using the URR, the delivered dose should be equivalent to a Kt/V of 1.2, ie, an average URR of 65%. However, URR can vary substantially as a function of fluid removal.

B. To prevent the delivered dose of hemodialysis from falling below the recommended minimum dose, the prescribed dose of hemodialysis should be Kt/V 1.3. In terms of URR, a Kt/V of 1.3 corresponds to an average URR of 70%, but the URR corresponding to a Kt/V of 1.3 can vary substantially as a function of ultrafiltration.

C. The delivered dose of hemodialysis should be measured at least once a month in all adult and pediatric hemodialysis patients. The frequency of measurement of the delivered dose of hemodialysis should be increased when:

1.Patients are noncompliant with their hemodialysis prescriptions (missed treatments, late for treatments, early sign-off from hemodialysis treatments, etc.).2.Frequent problems are noted in delivery of the prescribed dose of hemodialysis (such as variably poor blood flows, or treatment interruptions because of hypotension or angina pectoris).3.Wide variability in urea kinetic modeling results is observed in the absence of prescription changes.4.The hemodialysis prescription is modified.

3.Urea Sampling

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A. Predialysis and postdialysis blood samples for measurement of BUN levels must be drawn at the same hemodialysis session.

B. Blood samples for BUN measurement must be drawn in a particular manner. Predialysis BUN samples should be drawn immediately prior to dialysis, using a technique that avoids dilution of the blood sample with saline or heparin.

C. Postdialysis BUN samples should be drawn using the slow flow/stop pump technique that prevents sample dilution with recirculated blood and minimizes the confounding effects of urea rebound.

D. Slow flow sampling technique:1. With the blood pump still running at 50 to 100 mL/min, draw

the blood sample for postdialysis BUN measurement from the arterial sampling port closest to the patient. Drawing the blood from the arterial sampling port ensures the postdialysis BUN measurement is performed on undialyzed blood.

2. Stop the blood pump and complete the patient disconnection procedure as per dialysis unit protocol.

E. Stop pump sampling technique.1. Immediately stop the blood pump.2. Clamp the arterial and venous blood lines. Clamp the arterial

needle tubing.3. Blood for postdialysis BUN measurement may be sampled by

needle aspiration from the arterial sampling port closest to the patient. Alternatively, blood may be obtained from the arterial needle tubing after disconnection from the arterial blood line and attaching a vacutainer or syringe without a needle.

4. Blood is returned to the patient and the patient disconnection procedure proceeds as per unit protocol.

F. Hemodialysis facilities should adopt a single BUN sampling method. If several different methods are used, the sampling method should be routinely recorded.

G. The sampling method used for a given patient should remain consistent. The predialysis and postdialysis BUN samples for a given patient should be processed in the same batch analysis at the laboratory.

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4.Adequate dosing

A. If the delivered Kt/V falls below 1.2 or the URR declines to <65%, on a single determination, at least one of the following actions should be performed:

1. Investigate potential errors in the delivery of the prescribed hemodialysis dose such as:

a. Clearance (K) less than assumed effective hemodialysis treatment.

b. Time (Td) less than prescribed. c. Errors in blood sampling or processing for BUN

concentration.2. Empirically increase the prescribed dose of hemodialysis.3. The impact of these corrective interventions should be followed

by performing more frequent measurements of Kt/V or URR.

5. Frequency of dialysis

A. The standard HD dose should be delivered as 4 hours. Even if the standards of adequacy such as dose expressed as eKt/V are reached, a minimum time of 12 h/week is desirable.

B. Treatment time and/or frequency should be increased in patients with hemodynamic instability or cardiovascular problems. The same may apply for the aged HD patients, who suffer more frequently from the above-mentioned conditions.

C. Long, slow, daily nocturnal HD: is performed 6-7 nights per week for 8-10 h during sleep at home. This may result in better control of blood pressure with reduced use of antihypertensive drugs, reduced incidence of intradialytic hypotension and cardiovascular complications. In addition there is increased weekly clearance of middle molecules and phosphate, with control of hyperphosphatemia without any phosphate binders.

D. Short/standard daily HD: Prolonged experience in a single unit with daily HD sessions of 2-2.5 h and 'standard efficiency' may have better control of hypertension and intradialytic fluid

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removal, improved nutritional status (increase in serum albumin, and dry weight), with substantial benefits in terms of well being. There is increased small- and middle-MW solute clearances and lower peak concentration of uremic toxins.

E. Dialysis duration up to 5.5 h is independently associated with survival even after adjustment of the relative risk of death by the dose of HD, either in terms of Kt/Vsp or eKt/V.

F. The more frequently intermittent HD is performed, the more it approaches continuous therapy.

6. Maximizing Patient Adherence to the Hemodialysis Prescription

A. Without compromising the delivered dose of hemodialysis, efforts should be undertaken to modify the hemodialysis prescription to prevent the occurrence of intradialytic symptoms that adversely affect patient comfort and adherence. These efforts may include one or more of the following:

1. Avoid excessive ultrafiltration.2. Slow the ultrafiltration rate.3. Perform isolated ultrafiltration.4. Increase the dialysate sodium concentration.5. Switch from acetate to bicarbonate-buffered dialysate.6. Reduce the dialysate temperature.7. Administer midodrine predialysis.8. Correction of anemia to the range recommended by Saudi

anemia guidelines.9. Administer supplemental oxygen.

VI. Common Infections in HD Patients

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1.Tuberculosis

A. Tuberculin skin test (purified protein derivative of tuberculin; PPD) should be performed in all high-risk patients such as immunosuppressed and malnourished patients.

B. TB should not be excluded by a negative PPD. C. All the dialysis patients with unexplained fever, weight loss,

anorexia, hepatomegaly, unexplained pulmonary infiltrates, pleural effusion, ascites, or lymph- adenopathy should be vigorously evaluated for an active focus of TB.

D. Prophylaxis of TB in HD patients with a positive PPD is recommended.

E. In patients with a negative PPD test, preventive therapy should be considered if they have been exposed to a patient with clinically active TB.

F. The principles of treatment of TB in the general population apply to dialysis patients but there are no controlled studies with regard to the optimum treatment regimen in HD patients. Modifications of dose are required for most antitubercular drugs in HD.

2.Viral Infection

A. Screening for hepatitis B virus (HBV) markers should be performed in all patients starting HD or transferring from another unit whether they received anti HBV vaccination or not.

B. Screening should be repeated every 3-6 months once on HD, depending on the prevalence of HBV infection in the unit. Screening for hepatitis C virus (HCV) antibodies should be performed in all patients starting HD or transferring from another unit.

C. Screening for HCV should be repeated at least every 6 months once on HD.

D. HCV screening should include an ELISA assay and a confirmatory testing with a more specific assay (RIBA).

E. Screening for HIV infection should be done in all patients starting HD or transferring from another unit. Once on routine HD, repeat

46

of screening is not recommended. F. Universal precautions for prevention of transmission of blood-

borne pathogens in the health care setting should be rigorously respected in all HD units. These include:

1. Cleaning and disinfection of instruments, machines and environmental surfaces after each treatment.

2. Appropriate disposal of linens,sheets and used disposables.3. Avoidance of sharing articles among patients.4. Frequent hand washing and use of disposable gloves.5. Use of protective eye wear and face mask.

G. Dialyzed HBsAg-positive patients should be treated in separate rooms with dedicated machines.

H. In addition to universal precautions, which are the most efficacious preventive measures, treatment of anti- HCV patients in separate areas with dedicated staff is recommended in units with a high prevalence of HCV infection..

I. Passive immunization or passive-active immunization against HBV should be applied for post-exposure protection after accidental inoculation in staff as preventive treatment in both health care workers and dialysis patients when unresponsive to vaccination.

J. A combination of AZT, lamivudine, and a protease inhibitor should be recommended for HD staff members accidentally exposed to HIV.

K. Active immunization against HBV should be undertaken in all HD staff members.

L. Either a 0-, 1-, 6-month or a 0-, 1-, 2- and 12-month vaccination schedule should be used.

M. Monitoring of acquired antibody titre is advisable in these subjects. Additional doses should be administered to staff members who do not develop protective antibody titres (threshold level 10 mIU/ml).

N. Patients with progressive chronic renal failure should be vaccinated against HBV preferably before they start onHD.

O. HD patients who have not been previously immunized against HBV should be vaccinated.

P. Anti-HBs testing is recommended 1-2 months after the primary series has been completed and 6-12 months thereafter, depending

47

on the local incidence of HBV infection. Additional doses should be administered to patients who do not develop protective antibody titres (threshold level 10 mIU/ml). Subsequent routine testing is recommended every 6 months. A booster dose is recommended if the anti-HBs titre is less than 10 mIU/ml.

Q. To inhibit HBV replication, alpha interferon (IFNa) and/or lamivudine should be administered to transplant candidates who have biopsy-proven HBV-chronic liver disease.

R. IFNa should be considered for HD patients with biopsy-proven chronic hepatitis due to HCV awaiting renal transplantation.

3.Vaccinations

A. Pneumococcal polysaccharide vac-cine is recommended especially in the elderly HD patients. Revaccination is also recommended 5 years after the previous dose.

B. Influenza vaccine is recommended annually before the beginning of the influenza season for HD patients.

C. Patient on dialysis should receive the diphtheria and tetanus toxoids as recommended for healthy persons.

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VII. Cardiovascular Risk Factors in Hemodialysis patients

A. Patients' cardiovascular risk should be formally assessed and documented at the onset of haemodialysis and 6 monthly thereafter. Risk assessment includes modifiable risk factors such as cigarette smoking, hyperglycemia, dyslipidemia, and hypertension.

B. All patients should have total cholesterol, triglycerides, and HDL cholesterol measured at presentation, and 3 months after beginning of hemodialysis.

C. LDL cholesterol should be calculated by the Friedewald formula (LDL cholesterol= total cholesterol- (HDL cholesterol+triglyceride/5) when triglycerides are 400 mg/dl (4.56 mmol/L). For triglycerides between 400 and 800 mg/dl (4.56-9.12 mmol/L) direct LDL measurements should be done.

D. All blood collections for lipid screening should be performed, whenever possible, on patients in the fasting state. When screening for dyslipidaemia is done, blood should be drawn immediately before or at least 12 h after a regularly scheduled hemodialysis treatment.

E. Patients should have a complete lipid profile measured every 6 weeks during the initiation phase of lipid lowering intervention. When target levels have been met the frequency can be reduced to every 4-6 months.

F. Any patient with elevated LDL cholesterol or other forms of dyslipidaemia (elevated total cholesterol and triglycerides and/or low HDL cholesterol) should undergo clinical or laboratory assessment to rule out other secondary causes such as glucose intolerance, hypothyroidism, obstructive liver disease, alcohol abuse, or drugs that decrease HDL cholesterol..

G. Screening for dyslipidemia should not be performed after surgery or during conditions, which may acutely affect the lipid profile.

H. Patients without any comorbid conditions and a low total cholesterol (<150 mg/dl; 3.9 mmol/L) should be investigated for possible nutritional deficits.

I. Patients with elevated LDL cholesterol (100-129 mg/dl; 2.6-3.4 mmol/L) should be treated to achieve LDL cholesterol <100 mg/dl,

49

J. Treatment beyond LDL cholesterol lowering should be initiated in patients with triglycerides > 180 mg/dl (2.0 mmol/L). In patients with LDL cholesterol 100-129 mg/dl (2.6-3.4 mmol/L) or triglycerides > 180 mg/dl (2.0 mmolul) therapeutic lifestyle changes should be initiated, whenever possible.

K. Patients with dyslipidaemia should have dietary interviews and/or diaries focusing on the type and amount of fat. Dietary interviews should be repeated in yearly intervals when target lipid levels are not met during concomitant drug therapy.

L. If after 3 months of therapeutic lifestyle changes, LDL cholesterol is > 100 mg/dl (2.6 mmol/Ll) treatment with a HMG-CoA reductase inhibitor should be initiated.

M. If LDL cholesterol goal is not achieved after 6 weeks of treatment the dose of the HMG-CoA reductase inhibitor should stepwise be increased and a lipid profile be repeated after another 6 weeks.

N. If LDL cholesterol goal is not achieved with therapeutic lifestyle changes and optimal treatment with a HMG-CoA reductase inhibitor additional measures should be considered.

O. Patients with triglycerides between 180-499 mg/dl (2.0-5.7 mmol/L, after 3 months of therapeutic lifestyle changes, should be treated with a HMG-CoA reductase inhibitor, to achieve a non-HDL cholesterol < 130 mg/dl.

P. Patients with very high triglycerides >500 mg/dl (6 mmol/l) should be treated with a fibric acid analogue with the dose adjusted according to renal function.

Q. In patients with triglycerides > 800 mg/dl (9 mmol/L), resistant to any intervention, the administration of fish oil and/or a switch to low-molecular weight (LMW) heparin as anticoagulant during hemodialysis therapy should be considered.

R. Combining a fibric acid analogue with a HMG-CoA reductase inhibitor should be avoided due to the high risk of rhabdomyolysis.

S. Serum calcium and phosphate should be measured in routine intervals and obtained immediately before the hemodialysis session starts.

T. When serum phosphate is elevated you may consider recirculation and investigate effective duration of dialysis treatment.

U. The target range of serum phosphorus in dialysis patients should

50

be 0.8-1.8 mmol/L (2.5-5.5 mg/dl) aiming for a normal Ca x P ion product (55 mg2dl2)

V. Serum calcium and phosphate should be measured in routine intervals and obtained immediately before the hemodialysis session starts.

W. Lp(a) should be measured in patients with a long life expectancy on renal replacement therapy in 6-month intervals in order to quantify risk for subsequent cardiovascular disease.

X. In young patients with a long life expectancy on renal replacement therapy and an Lp (a) 30 mg/dl, the apo (a) isoform should be determined.

Y. Determination of plasma fibrinogen, as a marker of myocardial damage and activated acute-phase response, is recommended at 6-month intervals to appropriately assess cardio-vascular disease risk.

Z. Smokers with plasma fibrinogen >3 g/dl should vigorously be encouraged to stop smoking in order to decrease plasma fibrinogen.

AA.Folate therapy can be administered in order to lower total plasma homo-cysteine. Folate therapy should always be combined with vitamins B6 and B12.

BB. C-reactive protein (CRP) testing should be included in the routine laboratory evaluation for risk evaluation and stratification in stable patients. Measurements should be done at least in 3 monthly intervals.

CC. Patients with CRP > 8 mgul should be screened for silent infection of hemodialysis access grafts, para- dontitis or any low-grade infection.

DD. In patients with elevated CRP > 8 mg/dl) biocompatibility of dialyzer membrane and hemodialysis fluid quality should be checked.

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215. Sulimani F A, Al-Daif AK, Mitwalli A, Huraib S Isoniazid induced acute confusional state in a patient on hemodialysis. Saudi Kidney Dis Transplant Bull 1991; 2(1):29-32.

216. Ayoola EA, Huraib S, Arif M, al-Faleh FZ, al-Rashed R, Ramia S, al-Mofleh IA,Abu-Aisha H. Prevalence and significance of antibodies to hepatitis C virus among Saudi hemodialysis patients. J Med Virol. 1991;35(3):155-9.

217. Mitwalli A.Tuberculosis in patients on maintenance dialysis. Am J Kidney Dis. 1991 Nov;18(5):579-82.

218. George A, Paul T T, Kedharnath C, Want M A, Joshi M K, Diwan M, Mon H. A clinical study of permanent vascular access in hemodialysis patients. Saudi Kidney Dis Transplant Bull 1991;2(2):74-78.

219. Souqiyyeh M Z, Kabir M Z. Postpartum hemolytic-uremic syndrome. Saudi Kidney Dis Transplant Bull 1991;2(2):89-92.

220. Aldrees A, Paul T. T, Abu-Aisha H, Babiker M A, Kurpad R , Aswad S. Cost evaluation of hemodialysis in ministry of health hospitals, Saudi Arabia: A NKF Study. Saudi Kidney Dis Transplant Bull 1991;2(3):125-133.

221. Souqiyyeh MZ, Huraib SO, Saleh AG, Aswad S.Pregnancy in chronic hemodialysis patients in the Kingdom of Saudi Arabia. Am J Kidney Dis. 1992 Mar;19(3):235-8.

222. Hussein M, Mooij J, Roujouleh H. Spectrum of pericarditis among hemodialysis patients experience in a single center Saudi Kidney Dis Transplant Bull 1992;3(2):89-94

223.Mahmoud A M, El-Sibai M A. Intra-atrial permanent catheter: A long-term vascular access for hemodialysis in small children Saudi Kidney Dis Transplant Bull 1992; 3(2):101-104.

224. Hussein M, Mooij J, Roujouleh H. The use of biocompatible membrane (AN 69)

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dialyzers in chronic hemodialysis patients: a preliminary report. Saudi Kidney Dis Transplant Bull 1993;4(3):220-224.

225. Hussein MM, Mooij JM, Roujouleh H, el-Sayed H.Observations in a Saudi-Arabian dialysis population over a 13-year period. Nephrol Dial Transplant. 1994; 9(8):1072-6.

226.Al-Koussi M, Tohamy M. Ali, El Kareimy IR, Kamel NAH, Menawy L, Sheikh IA, Shaheen FAM. Can uremia and hemodialysis affect plasma levels of circulating TNF-α. Saudi J Kidney Dis Transplant 1994;5(2):163-167.

227. Al Shohaib S, El Johary M, Zawawi T. Complications of subclavian catheterization in hemodialysis patients. Saudi J Kidney Dis Transplant 1994;5(4):479-482.

228. Huraib S, al-Rashed R, Aldrees A, Aljefry M, Arif M, al-Faleh FA.High prevalence of and risk factors for hepatitis C in haemodialysis patients in Saudi Arabia: a need for new dialysis strategies. Nephrol Dial Transplant. 1995;10(4):470-4.

229. al-Faleh FZ, Huraib S, Sbeih F, al-Karawi M, al-Rashed R, al-Mofleh IA, Sougiyyah M, Shaheen M, Ramia S. Hepatitis C virus genotypes in patients with chronic liver disease and hemodialysis patients from Saudi Arabia. J Viral Hepat. 1995;2(6):293-6.

230. Ahmad M S , Mahtab A M, Al Shaibi A, Amin Tashkandy M, Kashreed M S D, Maulana A. Prevalence of antibodies against the hepatitis C virus among voluntary blood donors at a Makkah hospital. Saudi Arabia Saudi J Kidney Dis Transplant 1995;6(2):122-124.

231. Al-Muhanna FA. Hepatitis C virus infection among hemodialysis patients in the eastern region of Saudi Arabia. Saudi J Kidney Dis Transplant 1995;6(2):125-7.

232. Al Shohaib S S, Abdelaal M A,. Zawawi TH, Abbas FM, Shaheen FA.M, Amoah E The prevalence of hepatitis C virus antibodies among hemodialysis patients in Jeddah area, Saudi Arabia Saudi Arabia Saudi J Kidney Dis Transplant 1995;6(2):128-131.

233. Bernieh B, Allam M, Halepota A, Mohamed A O, Parkar J, Tabbakh A Prevalence of hepatitis C virus antibodies in hemodialysis patients in Madinah Al Munawarah. Saudi J Kidney Dis Transplant 1995;6(2):132-135.

234. Shaheen FA.M., Huraib S O, Al-Rashed R, Aldrees A, Arif M , Al Jeffry M, Tashkandy MA , Safwat M Prevalence of hepatitis C antibodies Among hemodialysis patients in the Western Province of Saudi Arabia. Saudi J Kidney Dis Transplant 1995;6(2):136-139.

235. Omer M N, Tashkandy MA, El Tonsy A H. Liver enzymes and protein electrophoretic patterns in hemodialysis patients with antibodies against the hepatitis C virus. Saudi J Kidney Dis Transplant 1995;6(2):163-166.

236. Souqiyyeh M Z, Shaheen F A.M, Huraib S O, Al-Khader A A. The annual Incidence of seroconversion of antibodies to the hepatitis C virus in the hemodialysis population in Saudi Arabia. Saudi J Kidney Dis Transplant 1995;6(2):167-173.

237. Abu-Aisha H, Mitwalli A, Huraib S O, Al-Wakeel J, Abid J, Yousif KI. , Algayyar F, Ramia S. The effect of chemical and heat disinfection of the

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hemodialysis machines on the spread of hepatitis C virus infection: A prospective study Saudi J Kidney Dis Transplant 1995;6(2):174-178.

238. Qattan N MS, Dahduli S, Al Jabreen M.Grafts for hemodialysis access: Results and complications Saudi J Kidney Dis Transplant 1995;6(4):403-406.

239. Souqiyyeh MZ, Paul TT, Ramprasad KS, Attar MB, Asim G, Ibrahim SA, Babiker MA, Qayum A, Tayeb A, Ikram M, al-Khanani H, Shaheen FA. Role of computers in coordination of renal care facilities: experience in the Kingdom of Saudi Arabia. Transplant Proc. 1996 Feb;28(1):252-3.

240. Soyannwo MA, Khan N, Kommajosyula S, Abdel Rahman AR, Khadaji M, Sing R, Laithy SU, Ladha A, Azzam A, Desmukh S. Hepatitis C antibodies in hemodialysis and pattern of end-stage renal failure in Gassim, Saudi Arabia. Afr J Med Med Sci. 1996 Mar;25(1):13-22.

241.al-Mugeiren M, al-Rasheed S, al-Salloum A, el-Zouki A, al-Sohaibani M, al-Fawaz, Al-Homrany M. Successful therapy of tuberculosis in hemodialysis patients. Am J Nephrol. 1997;17(1):32-5.

242. Kumar R Misha HK. Acquired cystic renal disease in patients receiving long-term hemodialysis Saudi J Kidney Dis Transplant 1997;8(1):8-10.

243. Sulaiman I. Pregnancy in hemodialysis patients Saudi J Kidney Dis Transplant 1997;8(1):32-35

244. Al-Salman MM.S. Rabee H, Abu-Aisha H, Trengganu N, Al-Damegh S, Al-Smeyer S, Freigoun T. Central vein stenosis in patients with prior subclavian vein catheterization for maintenance dialysis. Saudi J Kidney Dis Transplant 1997;8(2):119-122.

245. Kumar R. Hepatitis C virus infection among hemodialysis patients in the Najran Region of Saudi Arabia Saudi J Kidney Dis Transplant 1997;8(2):134-137.

246. Taminu D Z, Huraib S O., Gorka W, Abu Romeh S, Quadri K M, Al Turki S, Iqbal A, Flaiw A. Doppler ultrasound evaluation of hemodialysis vascular access Saudi J Kidney Dis Transplant 1998;9(1):8-11.

247. Al-Wakeel JS. Post-dialysis solutes rebound: comparison of two protocols for hemodialysis Saudi J Kidney Dis Transplant 1998;9(2):139-143.

248. Al-Homrany M, Wali M, Abu-Eshy S, El-Tawail M, El-Taher A M Fatal complication of percutaneous femoral vein catheterization in a hemodialysis patient Saudi J Kidney Dis Transplant 1999;10(1):59-63.

249. Al Shohaib S. Tuberculosis in chronic renal failure in Jeddah. Int Urol Nephrol. 1999;31(4):571-5.

250.al-Muhanna FA, Saeed I, al-Muelo S, Larbi E, Rubaish A. Disease profile, complications and outcome in patients on maintenance haemodialysis at King Faisal University Hospital, Saudi Arabia. East Afr Med J. 1999 Dec;76(12):664-7.

251. Mohamed A O,. Sirwal I A, Bernieh, Ahmed M. Patients on hemodialysis visiting Madina Munawarah: Communication between nephrologists. Saudi J Kidney Dis Transplant 2000;11(1):31-34.

252.Jamal A, Subramanian P.T., Hussain K. S A. Nail changes in end-stage renal failure patients on hemodialysis. Saudi J Kidney Dis Transplant 2000;11(1):44-7.

253. Jamal Arshad, Subramanian P.T. Pruritus among end-stage renal failure patients on hemodialysis. Saudi J Kidney Dis Transplant 2000; 11(2):181-185.

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254. Tanimu D, Huraib Sr, Shaheen FA.M., Hejaili F, Giles C, Pagayon V. The effect of vitamin E-modified dialyzers on acute intra-dialytic symptoms: a comparative crossover study. Saudi J Kidney Dis Transplant 2000;11(4):543-7.

255.Al-Salman M M.S., Fares A M.E, Rabee H M.M, Murtuza A M. Effect of arteriovenous fistula for hemodialysis on limb circulation Saudi J Kidney Dis Transplant 2000;11(4):548-552.

256.Al Shohaib S. Tuberculous peritonitis in hemodialysis patients with chronic liver disease. Saudi J Kidney Dis Transplant 2000; 11(4):577-582.

257.Al-Ghamdi S M.G, Al-Harbi AS Hepatitis C virus sero-status in hemodialysis patients returning from holiday: another risk factor for HCV transmission. Saudi J Kidney Dis Transplant 2001; 12(1):14-20.

258. Subramanian PT, Jamal A, Shah M Y. Hemodialysis utilization in a single in-center dialysis unit in the Kingdom of Saudi Arabia Saudi J Kidney Dis Transplant 2001;12(1):64-74.

259. AL-Homrany M A, Bilal A M.Psycho-social fatures of chronic dialysis pients in Saudi Arabia: Experience of one Centre Saudi J Kidney Dis Transplant 2001; 12(2):164-171.

260. Al Dayel AG, Al Oraifi I, Ezzibdeh M Y, Egail S A, El Sayed Essam, Abou Zallat A, Al Zahrani S. Stretch plytetrafluoroethylene gafts for hmodialysis agioaccess: Three-year experience.Saudi J Kidney Dis Transplant 2001;12(2):172-174.

261.Souqiyyeh M Z, A. Al-Attar M B, Zakaria H, Shaheen FA.M. Dialysis centers in the kingdom of Saudi Arabia.Saudi J Kidney Dis Transplant 2001;12(3):293-304.

262. Mitwalli A H., Abed J., Tarif N., Alam A., Al-Wakeel J.S., Abu-Aisha H, Memon N, Sulaimani F, Ternate B, Mensah M.O. Dialyzer Reuse impact on dialyzer Efficiency, Patient Morbidity and Mortality and Cost Effectiveness Saudi J Kidney Dis Transplant 2001;12(3):305-311.

263. Al-Khader A A, Ramprasad KS,. Shaheen F A.M. The need for guidelines for the practice of hemodialysis in the Kingdom of Saudi Arabia: a Questionnaire Survey.Saudi J Kidney Dis Transplant 2001;12(4):494-502.

264. Saxena AK, Panhotra BR, Naguib M, Uzzaman W, Al MK. Nosocomial transmission of syphilis during hemodialysis in a developing country. Scand J Infect Dis. 2002;34(2):88-92.

265. Saxena AK, Panhotra BR, Naguib M, Sundaram DS, Venkateshappa CK, Uzzaman W, Al-Mulhim K. Outcome of dialysis access-related septicemia among diabetics following optimized AV-fistula placement. Kidney Blood Press Res. 2002;25(2):109-14.

266. Ayoola EA, Want MA, Gadour MO, Al-Hazmi MH, Hamza MK. Hepatitis E virus infection in haemodialysis patients: a case-control study in Saudi Arabia. J Med Virol. 2002 Mar;66(3):329-34.

267. Saeed Abdulrahman I, Al-Mueilo SH, Bokhary HA, Ladipo GO, Al-Rubaish A.A prospective study of hemodialysis access-related bacterial infections. J Infect Chemother. 2002 Sep;8(3):242-6.

268. Dahduli SA, Qattan NM, Al-Kuhaymi RA, Al-Jabreen MA, Al-Khader AA. Mobilization and superficialization of basilic vein for brachio basilic fistula.

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Saudi Med J. 2002 Oct;23(10):1203-5. 269. Bhat A, Solangi S, Osman M. Nosocomial infective endocarditis in hemodialysis

Saudi J Kidney Dis Transplant 2002;13(2):181-184270.Al Wakeel J S, Mitwalli A H., Mohaya S. A, bu-Aisha H, Tarif N, Malik GH.,

Hammad D. Morbidity and mortality in ESRD patients on dialysis Saudi J Kidney Dis Transplant 2002;13(4):473-477.

271. Saxena AK, Panhotra BR, Sundaram DS, Naguib M, Venkateshappa CK, Uzzaman W, Mulhim KA. Impact of dedicated space, dialysis equipment, and nursing staff on the transmission of hepatitis C virus in a hemodialysis unit of the middle east. Am J Infect Control. 2003 Feb;31(1):26-33.

272. Al-Jondeby MS, Cabaguing IT, Pajarillo AA, Hawas FA, Mousa DH, Al-Sulaiman MH, Shaheen FA, Al-Khader AA. Comparative crossover controlled study using polysulphone and vitamin E coated dialyzers. Saudi Med J. 2003 Mar;24(3):265-8.

273.Bouraoui S. G, Skhiri H.,. Achour A, Frih A., Ben DhiaN,. Hammami S. El May M. The predictors of early mortality in patients starting chronic hemodialysis. Saudi J Kidney Dis Transplant 2003;14(1):23-29.

274. Saxena AK., Panhotra B.R. The prevalence of nasal carriage of Staphylococcus aureus and associated vascular access-related septicemia among patients on hemodialysis in Al-Hasa Region of Saudi Arabia. Saudi J Kidney Dis Transplant 2003; 14(1):30-38.

275.Al-Jiffri A M Y., Fadag R B.,. Ghabrah T M, Ibrahim A. Hepatitis C virus infection among patients on hemodialysis in Jeddah: a single center experience. Saudi J Kidney Dis Transplant 2003; 14(1):84-89.

276. Abul Kashem Nusairat I, Mohamad M, Ramzy M, Nemma J, Karim M.R, Divakaran MP, Tayaab A S. Hepatitis C Virus among hemodialysis patients in Najran: Prevalence is more among multi-center visitors. Saudi J Kidney Dis Transplant 2003;14(2):206-211.

277. Souqiyyeh M Z, Shaheen FA.M. Attitude of physicians in Saudi Arabia towards heparin administration and monitoring in hemodialysis patients. Saudi J Kidney Dis Transplant 2003; 14(4):475-480.

278. Saxena AK, Panhotra BR. The vulnerability of middle-aged and elderly patients to hepatitis C virus infection in a high-prevalence hospital-based hemodialysis setting. J Am Geriatr Soc. 2004;52(2):242-6.

279. Saxena AK, Panhotra BR. The impact of nurse understaffing on the transmission of hepatitis C virus in a hospital-based hemodialysis unit. Med Princ Pract. 2004 May-Jun;13(3):129-35.

280. Saxena AK, Panhotra BR, Chopra R. Advancing age and the risk of nasal carriage of Staphylococcus aureus among patients on long-term hospital-based hemodialysis. Ann Saudi Med. 2004 Sep-Oct;24(5):337-42.

281.Al-Ghamdi S MG. Nurses’ knowledge and practice in hemodialysis units: comparison between nurses in units with high and low prevalence of hepatitis C virus Infection. Saudi J Kidney Dis Transplant 2004; 15(1):34-40.

282.Raza H, Courts A, Quadri K, Qureshi J, Al Ghamdi G, Al Flaiw A, Al Hejaili F, Huraib S. The effect of active nutritional counseling in improving biochemical

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nutritional parameters and fluid overload problems in maintenance hemodialysis patients. Saudi J Kidney Dis Transplant 2004; 15(2):140-143.

283. Sobki SH, Al-Etah H , El Gezeery A, Al Khader A. effect of age on pituitary gonadal hormonal responses of Saudi male patients on hemodialysis Saudi J Kidney Dis Transplant 2004;15(4):447-454.

284. Shaheen FA, Kurpad R, Al-Attar BA, Muna B, Al-Khader AA. Comparative psychosocial analysis of patients on maintenance hemodialysis and transplanted patients. Ann Transplant. 2005;10(1):17-21.

285. Malik GH, Al-Harbi A, Al-Mohaya S, Dohaimi H, Kechrid M, Shetaia MS, Al-Hassan AO, Quiapos LS. Pregnancy in patients on dialysis--experience at a referral center. J Assoc Physicians India. 2005 Nov; 53: 937-41.

286. Mitwalli A H,. Al-Wakeel J S , Alam A, Tarif N, Abu-Aisha H, Rashed M, Al Nahed N. L-Carnitine Supplementation in Hemodialysis Patients Saudi J Kidney Dis Transplant 2005;16(1):17-22.

287. Badawi L, Akeel N, Shaheen F AM, Al Ahmadi S. Dose and lipid lowering effect of tinzaparin sodium: a single center experience Saudi J Kidney Dis Transplant 2005;16(2):161-165.

288. Al-Harbi ASB, Malik G H,. Subaity Y, Mansy H,. Abutaleb N Treatment of acute hepatitis C virus infection with alpha interferon in patients on hemodialysis Saudi J Kidney Dis Transplant 2005;16(3):293-297.

289. Mohamed A O. Morbidity and mortality in ESRD patients on regular hemodialysis: a single center experience. Saudi J Kidney Dis Transplant 2005;16(3):336-341.

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Disclaimer

These Guidelines are based upon the best information available at the time of publication. They are designed to provide information and assist decision-making. They are not intended to define a standard of care, and should not be construed as one. Neither should they be interpreted as prescribing an exclusive course of management. Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every health-care professional making use of these Guidelines is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation.

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