duralock c catheter lock solution med comp. duralock c med comp protects against catheter related...

DURALOCK C

CatheterLock

Solution

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Duralock C

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• protects against catheter related infection

Duralock C

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• protects against catheter related infection• prevents the formation of biofilm

Duralock C

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• protects against catheter related infection• prevents the formation of biofilm• prevents catheter clotting use of thrombolytic agents

Duralock C

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Literature shows catheter related bacteremia incidence of

3,0 – 7,0 episodes/1.000 cath.days

Duralock C

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Literature shows catheter related bacteremia incidence of

3,0 – 7,0 episodes/1.000 cath.days

Tunneled Non tunneled

Duralock C

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Most cultured microbes:

• S. aureus • Coagulase negative s. aureus• S epidermidis• Candida albicans• E. Agglomerans• P. aeruginosa• Enterococcus faecalis

Duralock C

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Consequenses of CRB: • Serious complications in the use of catheters

Duralock C

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Consequenses of CRB: • Serious complications in the use of catheters• High cost treatment:

- catheter exchange- hospitalization (for example for IV treatment with antibiotics

Duralock C

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• Interruption of treatment

Duralock C

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• Interruption of treatment• Increasing problem of antibiotic resistance

Power of Duralock C

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Power of Duralock C

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Concentrated Sodium Citrate (23%) for Catheter Lock Stephen R. Ash et al, Hemodialysis International 4:22-31, 2000

Protocol:• 40 patients followed for several catheter locking solutions:

1/98-8/98: heparin 5000 units or 10 000 units 9/98-11/98: 10% sodium citrate (pH 6.5) with 3 mg/mL gentamicin 12/98-3/99: 20% sodium citrate with 3 mg/mL gentamicin 4/99-6/99: 46,7% sodium citrate 7/99-10/99: heparin 5000 or 10 000 units 11/99-3/00: 23% sodium citrate

Study endpoints:• The incidence of symptomatic bactaeremia (calculated as the number of episodes per 3000 patient-days)• Use of urokinase

Power of Duralock C

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Infection Rate

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Heparin 5000 IU/mlTrisodium citrate 30%

Nephrol Dial Transplant (2002) 17: 2189–2195

M.C. Weijmer, Y.J. Debets-Ossenkopp, F.J. van de Vondervoort and P.M. ter Wee

Power of Duralock C

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0

5

10

15

20

25

30

35

40

Heparine Trisodiumcitrate2.2%

Trisodiumcitrate7.5%

Trisodiumcitrate15%

Trisodiumcitrate30%

Trisodiumcitrate7.5%/ gentamicin

1mg/ml

mmS. aureus

E. coli

S. epidermidis

P. aeruginosa

C. albicans

Disk Diffusion Susceptibility Test

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Heparin 5000 IU/ml



Primary endpoint:Catheter survival

Secondary endpoints - infection - bacteremia

- exit site infection

- thrombosis - flow problems- use of urokinase

- side effects - bleeding- thrombocytopenia- systemic reactions after locking

Study design

Interimanalysis(200 catheters)

bacteremia

291 hemodialysis catheters

citrate 30% heparin total

Catheters tunneled cuffed

jugular

subclavian

femoral

untunneled

jugular

subclavian

femoral

148 50

49

1

0

98

77

1

20

143 48

48

0

0

95

69

2

24

291 98

97

1

0

193

146

3

48

Catheter days 8431 8116 16547

Days per catheter tunneled cuffed

untunneled

57.0 97.1

36.5

56.8 94.2

37.8

56.9 95.7

37.1

Power of Duralock C

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Why protects a citrate solution against catheter related infections?

Power of Duralock C

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Why protects a citrate solution against catheter related infections?

Citrate =

combined with

citric acid = C3H5O(COO)33−

binds

double positive ionized molecules: Ca++ / Mg++

Na3C6H5O7

Power of Duralock C

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Apart from Mg++ binding, removal of Ca++ fromthe surrounding milieu can be an explanation for theantimicrobial properties of TSC. Ca++ may regulateseveral genes responsible for growth and survival ofmicrobes. Holland et al. [19] demonstrated that celldivision in E.coli in particular appears to be verysensitive to the level of cellular Ca++.

Weijmer MC, Debets-Ossenkopp YJ, Van de VondervoortFJ, ter Wee PM: Superior antimicrobial activity of trisodiumcitrate over heparin for catheter locking. Nephrol DialTransplant 17: 2189–2195, 2002

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“We conclude that in our in vitro study using standardized antimicrobial susceptibility tests we demonstrated that TSC 30% was the most potent antimicrobial locking solution and that its hyperosmolality was of minor importance to explain the inhibitory effects of TSC on microbial growth.”

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Randomized, Clinical Trial Comparison of Trisodium Citrate 30% and Heparin as Catheter-Locking Solution inHemodialysis PatientsMarcel C. Weijmer, Marinus A. van den Dorpel, Peter J.G. Van de Ven, Pieter M. ter Wee, Jos A.C.A. van Geelen, Johannes O. Groeneveld, Brigitte C. van Jaarsveld, Marjon G. Koopmans, Caatje Y. le Poole, Anita M. Schrander-Van der Meer, Carl E.H. Siegert, Koen J.F. Stas; for the CITRATE Study Group

Catheter survival

46

28

0

5

10

15

20

25

30

35

40

45

50

% catheterspreliminary removed

heparin

citrate 30%

heparin

TSC

P=0.014

days in place

18%

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Bacteremia free survival

33

9

0

5

10

15

20

25

30

35

total episodesbacteremia

heparin

citrate 30%

P=0.0002

heparin

TSC

days in place

73%

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P=0.002

21

6

0

5

10

15

20

25

30

admissions dueto infections

P=0.001

245

440

25

50

75

100

125

150

175

200

225

250

hospital days due toinfections

heparine

citraat 30%

Infection related admissions

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P=0.35

Mortality

18

13

0

2

4

6

8

10

12

14

16

18

20

overall

0

P=0.022

5

Bacteremia related

heparin

citrate 30%

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• Prevents formation of biofilm

Duralock C

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Duralock C

Micro organisms

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Duralock C

Biofilm grows under the influence of poly sacharides, produced by micro organisms.

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Duralock C


Heparin is a poly sacharide combined with an anti thrombin

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Heparin is a poly sacharide combined with an anti thrombin

Heparin induces the growth of biofilm

Method:…examined 42 arterial and 26 central venous catheters that had been in place in ICU patients between 1 and 14 days for the presence of bacterial biofilms by scanning electron microscopy, transmission electron microscopy, and a special scraping/sonication bacterial recovery technique.

Crit Care Med. 1992 May;20(5):665-73.

Biofilms on indwelling vascular catheters, Passerini. L, Lam K, Costerton JW, King EG

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Duralock C

Crit Care Med. 1992 May;20(5):665-73.

Biofilms on indwelling vascular catheters, Passerini. L, Lam K, Costerton JW, King EG

Conclusion: 1. Extensive biofilm formation on all 42 arterial and 26 central

venous catheters. 2. Bacteria within the biofilms on 69% (29/42) of the arterial and

88% (23/26) of the central venous catheters.

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Catheter lock solutions influence staphylococcal biofilm formation on abiotic surfaces

Robert M. Q. Shanks1, Jennifer L. Sargent1, Raquel M. Martinez1, Martha L. Graber2 and George A. O’Toole11Department of Microbiology and Immunology, Dartmouth Medical School, Hanover, NH 03755 and 2Department of Medicine, Section of Hypertension and Nephrology, Dartmouth Hitchcock Medical Center, Lebanon, NH 03766, USA

Nephrol Dial Transplant (2006) 1 of 9doi:10.1093/ndt/gfl170

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Catheter lock solutions influence staphylococcal biofilm formation on abiotic surfaces

Nephrol Dial Transplant (2006) 1 of 9doi:10.1093/ndt/gfl170

This in vitro study demonstrates that heparin alternatives, sodium citrate and sodiumEDTA, can prevent the formation of S. aureus biofilms, suggesting that they may reduce the risk of biofilm-associated complications in indwelling catheters.

Power of Duralock C

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• prevents catheter clotting use of thrombolytic agents

Duralock C

Catheter related thrombosis is often the cause of low catheter blood flows.

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Duralock C


Low blood flow inefficient treatment low Kt/V

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Duralock C


Low blood flow inefficient treatment low Kt/V

Treatment: Expensive thrombolitic agents (TpA, Urokinase, Streptokinase)

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Power of Duralock C

Under influence ofCa++

So...

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Power of Duralock C

Under influence ofCa++

So...

Binding Ca++ inthe catheter environment,stops the proces of clotting

Flow problems

getunneld = ongetunneld

20 18

0

5

10

15

20

25

30

% removed forflow problem

heparin

citrate 30%

heparin

TSCP=0.754

days in place

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Power of Duralock C

medCOMP Ash SR, et al. ASN 1999 A1375


Leakage lock solution

Bayes B et al, Nephrol Dial Transpl 1999; 14; 2532

Bleeding complications

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Duralock C

Power of Duralock C

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Sodium citrate for filling haemodialysis catheters

“We recommend filling the catheter with sodium citrate 46,7%

Bayes B et al, Nephrol Dial Transpl 1999; 14; 2532

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Duralock C

Bleeding complications

Risk of heparin lock-related bleeding when using indwelling venous catheters in haemodialysis, Hüseyin Karaaslan et al, Service de Néphrologie CHU Dupuytren, Limoges, FranceNephrol Dial Transpant, (2001) 16: 2072-2074

Bleeding complications during citrate-trial

P=0.005

19

6

0

2

4

6

8

10

12

14

16

18

20

After insertion

P=0.01

16

5

During follow up

heparin

citrate 30%

Consequences of leakage lock solution

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Cornelius J. Doorenbos, Marjo Van den Elsen-Hutten, Margret J. M. Heuven and Jan Hessels, Estimation of trisodium citrate (Citra-LockTM) remaining in centralvenous catheters after the interdialytic interval, Nephrology Dialysis Transplantation 2006 21(2):543-545

“The injected concentration Citra-Locktm decreases 30% in the inter dialytic periodein jugular and subclavian catheters. Femoral catheters show a decrease of 90%.

DURALOCK C

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30%

46,7%

30%Anti microbial protection, Weijmer)

DURALOCK C

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“The injected concentration Citra-Locktm decreases 30% in the inter dialytic periodin jugular and subclavian catheters. Femoral catheters show a decrease of 90%.

Literature reviews:1. Beathard GA: Management of bacteremia associated with tunneled-cuffed hemodialysis catheters. J Am Soc Nephrol 10: 1045–1049,

19992. Weijmer MC, ter Wee PM: Temporary vascular access for hemodialysis treatment. Current guidelines and future directions. Contrib

Nephrol 137: 38–45, 20023. Costerton JW, Stewart PS, Greenberg EP: Bacterial biofilms: A common cause of persistent infections. Science 284:1318–1322, 19994. Raad I: Intravascular-catheter-related infections. Lancet 351: 893–898, 19985. Bayes B, Bonal J, Romero R: Sodium citrate for filling haemodialysis catheters. Nephrol Dial Transplant 14: 2532–2533, 19996. Karaaslan H, Peyronnet P, Benevent D, Lagarde C, Rince M, Leroux-Robert C: Risk of heparin lock-related bleeding when using

indwelling venous catheter in haemodialysis. Nephrol Dial Transplant 16: 2072–2074, 20017. Dogra GK, Herson H, Hutchison B, Irish AB, Heath CH, Golledge C, Luxton G, Moody H: Prevention of tunneledhemodialysis catheter-related infections using catheter-restricted filling with gentamicin and citrate: A randomizedcontrolled study. J Am Soc Nephrol 13: 2133–2139, 20028. Weijmer MC, Debets-Ossenkopp YJ, Van de Vondervoort FJ, ter Wee PM: Superior antimicrobial activity of trisodium citrate over

heparin for catheter locking. Nephrol Dial Transplant 17: 2189–2195, 20029. Ash SR, Mankus RA, Sutton JM, Criswell ER, Crull CC, Velasquez KA, Smeltzer BD, Ing TS: Concentrated sodium citrate (23%) for

catheter lock. Hemodial Int 4: 22–31, 200010. Stas KJ, Vanwalleghem J, Moor BD, Keuleers H: Trisodium citrate 30% vs heparin 5% as catheter lock in the interdialytic period in

twin- or double-lumen dialysis catheters for intermittent haemodialysis. Nephrol Dial Transplant 16:1521–1522, 200111. Twardowski ZJ: High-dose intradialytic urokinase to restore the patency of permanent central vein hemodialysiscatheters. Am J Kidney Dis 31: 841–847, 199812. Buturovic J, Ponikvar R, Kandus A, Boh M, Klinkmann J, Ivanovich P: Filling hemodialysis catheters in the interdialytic period: Heparin

versus citrate versus polygeline: Aprospective randomized study. Artif Organs 22: 945–947,199813. Betjes MG, Van Agteren M: Prevention of dialysis catheterrelatedsepsis with a citrate-taurolidine-containing lock solution. Nephrol Dial

Transplant 19: 1546–1551, 200414. De Wachter DS, Weijmer MC, Kausylas M, Verdonck PR: Do catheter side holes provide better blood flows? Hemodial Int 6: 40–46,

200215. Twardowski ZJ: The clotted central vein catheter for haemodialysis. Nephrol Dial Transplant 13: 2203–2206, 199816. FDA Issues Warning on triCitrasol® Dialysis Catheter Anticoagulant.FDA Talk Paper T00-16, Rockville, MD, US Food and Drug

Administration, 2000

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Duralock C

Heparin– Anticoagulant

– Systemic effect

– Generates bleeding risks

– Promotes bacterial growth, poly sacharide is feed for micro organisms

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Duralock C

Heparin– Anticoagulant

– Systemic effect

– Generates bleeding risks

– Promotes bacterial growth, poly sacharide is feed for micro organisms

– Promotes formation of biofilm

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Duralock C

Conclusions:

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Power of Duralock C

1. Trisodium citrate, in a concentration of at least 30% shows an antimicrobial effect (Weijmer et al)

2. Trisodium citrate 30% shows a decrease of CRB of 75% in a randomized controlled multi centre trial (Weijmer et al).

3. Trisodium citrate 30% doesn’t effect positively on blood flow and use of thrombolytic agents (Weijmer et al)

4. Trisodium citrate 46,7% does show in In vivo studies a decrease in CRB and use of thrombolytic agents like Urokinase.

5. There is leakage of catheter lock solutions in the inter dialytic period, resulting in hight ATTP results, constantly measurable gentamycin levels or decreased trisodium citrate levels.

6. Catheter lock solutions based on antibiotics promote the risk of anti biotic resistance.

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DURALOCK C• No formation of biofilm• Anti microbial effect without anti biotics • No drug-resistant bacterial strains• No bleeding complications• Proven anticoagulant• Bio-compatible without systemic effects

Action plan- february1-5.2 8-12.2 15-19.2 22.26.2

פגישות עם מנהלי מחלקות

הנפרולוגיה

פגישות עם מנהלי מחלקות הנפרולוגיה

הצגת הדורה לוק בישיבות הצוות של

המחלקות

ליווי אבלואציות במחלקות הנפרולוגיה

הצגת הדורה לוק בישיבות הצוות של

המחלקות

התחלת אבלואציות במחלקות הנפרולוגיה

המשך צפייה בפרוצדורות

המחלקות האנגיו- 14:00-17:00שעות

המשך צפייה בפרוצדורות

המחלקות האנגיו- 14:00-17:00שעות

המשך צפייה בפרוצדורות המחלקות

-14:00האנגיו- שעות 17:00

Action plan- january

.118-22 25-29.1

22.1.09 מצגת דורה לוק- 26.1.09מצגת קטטרים לטווח קצר-

המשך צפייה בפרוצדורות -8:00המחלקות האנגיו- שעות

12:00

26.1.09הצגת דף הסבר דורה לוק-

תיאום פגישות עם הרופאים הרלוונטים- 29.1

המשך צפייה בפרוצדורות המחלקות 8:00-12:00האנגיו- שעות

Action plan- march1-5.3 8-12.3 15-19.3 22.26.3




הוצאת דרישות למוצר מול

מחלקות הרכש

הנפקת הצעות מחיר למנהלי מחלקות


הנפקת הצעות מחיר למנהלי מחלקות


מעקב אחר הזמנות למוצר מול

מחלקות הרכש

הוצאת דרישות למוצר מול מחלקות

הרכש

השתלבות במחלקות האנגיו

הרלוונטיות וחפיפה על הלקוח+

היכרויות עם מנהלי היחידות.

השתלבות במחלקות האנגיו הרלוונטיות וחפיפה על הלקוח+ היכרויות עם מנהלי

היחידות. השתלבות במחלקות האנגיו הרלוונטיות וחפיפה על הלקוח+ היכרויות עם מנהלי

היחידות.

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DURALOCK C

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