Date: 15 t h , october,2012

From,

Dr. B.M.Murthy

Post graduate,

Department of Medicine,

A.J.Institute of Medical Sciences,

Kuntikana, Mangalore.

To,

The Registrar,

RGUHS, 4th T block,

Jayanagar,

Bangalore-560041

Through the Head of the department of Medicine

Subject: Submission of synopsis of the dissertation to the Registrar,RGUHS.

I am here with submitting my MD dissertation synopsis titled “A STUDY OF ETIOLOGY,

CLINICAL PROFILE AND PROGNOSIS IN PATIENTS WITH ACUTE KIDNEY

INJURY” for the registration of dissertation to Rajiv Gandhi University of Health Sciences,

Bangalore. I request you to kindly do the needful.

Thanking you,Yours sincerely

Dr B.M.Murthy

Encl: as above

1

Proforma to be filled by the Principal Investigator (PI) for submission to Institutional Ethics Committee (IEC)

(for attachment to each copy of the proposal)

Serial No of IEC Management Office:

Proposal Title: “A STUDY OF ETIOLOGY, CLINICAL PROFILE AND PROGNOSIS IN PATIENTS WITH ACUTE KIDNEY INJURY”.

Name, Designation&

Qualifications

AddressTel & Fax Nos.

Email ID

Signature

Principal Investigator

Guide

Dr. B.M.Murthypostgraduate,Dept.of MedicineA.J.Institute of Medical Sciences.

M.B.B.S.

Dr. Ganesha Kumara KhandigeProfessorDept. of Medicine A.J.Institute of Medical Sciences.

M.B.B.S, M.D.(General Medicine)

S/O Dr.B.C.MugappaMugabasaveshwara clinic,Ujjini road,Kottur,Bellary-DistrictPh: +919739874302murthyktr@gmail.com

2-10-778/19PadmashreeІST floor, NoduBejai, New roadMangalore 575004

Curriculum Vitae of principal investigator and the guide (with subject specific publications limited to previous 5 years) – attached1.Type of Study:prospective study

2: Brief description of the proposal: The prevalence of anemia is more common in alcoholics and vegetarians compared to non-alcoholics and non-vegetarians.We are interested to study the incidence of anemia in alcoholics and non-alcoholics and vegetarians and non-vegetarians in AJIMS

2

3. Subject selection:i. Number of Subjects : all the patients who meet the inclusion criteria considered

in the study and who come to the out patient department during time period of this 2 years

ii. Duration of study : 2 years iii. Will subjects from both sexes be recruited: Yes

iv. Inclusion / exclusion criteria given: Yes

v. Type of subjects: Those who comes under AKIN CRITERIA above 18 years age

4. Privacy and confidentiality Confidential handling of data : Yes5. Consent : Please find it attached written informed consent i. Consent form : (included elements)

1. Understandable language 2. Statement that study involves research3. Statement that consent is voluntary4. Purpose and procedures 5. Risks & Discomforts 6. Benefits 7. Confidentiality of records8. Right to withdraw9. Contact information

ii. Who will obtain consent – Principal investigator6. Will any advertising be done for recruitment of Subjects? (posters, flyers, brochure, websites – if so kindly attach a copy) No

7. Risks & Benefits: No risks, but benefits to the research world 8. Is there compensation for participation? NoChecklist for attached documents:

1. Project proposal – 2 Copies2. Curriculum Vitae of Investigators3. Curriculum Vitae of Guide4. Informed Consent form 5. Copy of data collection Proforma

Place: Signature & Designation of Date: Principal investigator

3

CURRICULUM VITAE

Name : Dr.B.M.MurthyDate of Birth &Age : March 14rd 1983 -29yearsPresent Designation : PG/Junior ResidentDepartment : General medicine.College : A. J. Institute of Medical SciencesCity : MangaloreResidential address : S/o Dr.B.C.Mugappa Mugabasaveshwara clinic Ujjini road Kottur-583134 Bellary-district .

.Phone & fax number with code: Residence: -08391-226410 Email address : murthtyktr@gmail.com Mobile Number : 9739874302

PAN Number : BJEPB4269CQualification:

Qualification College University Year Registration number of UG & PG with date

Name of the state Medical Council

MBBS A.J. institute of medical sciences, Mangalore.

Rajiv Gandhi university of health sciences.

September 2003

9091905.01.2012

Karnataka medical council

Details of the previous appointments/ teaching experience:

Designation

Department Name of Institution

From DD/MM/YY

To DD/MM/YY

Total experience

in years and months

PG/ Jr. Resident

General medicine

A. J. Institute of Medical Sciences,

Mangalore

May 22, 2012

Till Date

4

CURRICULAM VITAE

Name : DR. GANESHA KUMARA KHANDIGEDate of Birth & Age : Feb 02, 1967 – 45Years Present Designation : Professor Department : GENERAL MEDICINECollege : A.J. Institute of Medical SciencesCity : MangaloreResidential Address :

MangalorePhone & Fax Number with code Office : 0824-2225533

Residence : 0824 – 2222712E- Mail id : gkhandige@yahoo.com Mobile Number : 9448488012PAN Number :

1.(i) Date of joining Present Institution : Jul 14, 2004 as Associate Professor

2. Qualifications:

Qualification College University Year Registration No. of UG & PG with

date

Name of the State

Medical Council

MBBS J J M Medical College, Davangere,

Mysore University

1989 30,722 dt. Sep 04, 1990

Karnataka Medical Council

MD(General Medicine)

J J M Medical College Davangere,

Kuvempu University

1995 30,722 dt Dec 31, 1998

Karnataka Medical Council

DM/M.Ch NA NA NA NA NA

3. Details of the previous appointments/teaching experience

Position Department Name of Institution FromDD/MM/YY

ToDD/MM/YY

Total Experience in years &

months

Sr.Resident

General Medicine

J J M Medical College Davangere, Mysore University

Jawaharlal Institute of Post-Graduate Medical Education and Research

July 1992

Dec 08, 1995

Sept. 1995

Mar 04, 1996

3 Years

3 Months

5

AssistantProfessor

General Medicine

Kasturba Medical College, Manipal

Jun 17, 1996

Jul 31, 2001 5 Years 1 Month

Associate Professor

General Medicine

A. J Institute of Medical Sciences, Mangalore

Jul 14, 2004 Sep 14, 2008 4 Years 2 Months

Professor General Medicine

A. J Institute of Medical Sciences, Mangalore

Sep 15,2008

Till Date

6

SYNOPSISSubmission for ethical clearance to Ethical Committee of AJIMS

“A STUDY OF ETIOLOGY, CLINICAL PROFILE AND PROGNOSIS IN

PATIENTS WITH ACUTE KIDNEY INJURY”

Name of the candidate : Dr. B.M.Murthy

Guide : Dr. Ganesha Kumara Khandige

Course and Subject : M.D. General Medicine

Department of Medicine,

A.J. INSTITUTE OF MEDICAL SCIENCES,

Kuntikana, Mangalore – 575004

2012

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1. Name of the candidate & address:(in block letters)

2. Name of the Institute:

3. Course of study and Subject: M.D.GENERAL MEDICINE

4. Date of admission to course: 22th May 2012

5.Title of the Topic: “ A STUDY OF ETIOLOGY, CLINICAL PROFILE

AND PROGNOSIS IN PATIENTS WITH ACUTE KIDNEY INJURY ”

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Dr. B.M.MURTHYPOSTGRADUATE STUDENT, DEPT. OF MEDICINE, AJ INSTITUTE OF MEDICAL SCIENCES, NH-17, KUNTIKANA, MANGALORE–575004.

AJ INSTITUTE OF MEDICAL SCIENCES, NH-17, KUNTIKANA, MANGALORE – 575004.

BRIEF RESUME OF THE INTENDED WORK:

6.1 Need for the study:

In India AKI constitutes 5% of hospital admission.

Causes of AKI are often multifactorial

Sepsis is the leading cause which constitutes about 45-75% of AKI. Among these 25-

35% of patients have severe sepsis. 40-55% of patients with septic shock die within

30 days.

6.2Review of literature:

1. AKI defined as any of the following

I. Increase in serum creatinine ≥0.3mg/dl with in 48hrs or

II. Increase in serum creatinine ≥1.5 times the baseline, which is known or presumed to

have occurred with in the prior 7 days or

III. Urine volume <0.5ml/kg/hr for 6hrs

2. Study by PRAKASH J.A et al. concluded that AKI in ICU is characterized by increased

Co-morbidity, high incidence of sepsis, MODS and mortality.

3. Program to improve care in acute renal disease(PICARD) study showed extensive co

morbidity associated with AKI; the main being coronary artery disease followed by diabetes

mellitus and chronic liver disease.

4. Presence of sepsis, MODS, higher AKIN score and ventilation needed for the patients were

correlated with higher mortality in AKI patients in the ICU setup.

6.3Objectives of the study:

To determine the cause, prognosis and outcome of AKI in patients admitted in

AJIMS

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7. Material and methods:

Source of Data: Hospital based study

Method of study: All patients who fullfil the inclusion criteria are included in the study after

obtaining an informed consent and these patients are followed up in the OPD for 1year

period.

Patients admitting to AJIMS.

Study design : Prospective study

Sample size: All the patients who fulfil the inclusion criteria considered in

the study and who come to the AJIMS during the time period of 1 year.

Sample: Patients attending AJ Institute of Medical Sciences

Place: A.J. Institute of medical sciences , Mangalore - 575004

Sample and sampling technique : Universal sampling technique

Study type: Prospective Study

Inclusion criteria: Patients who come under AKIN CRITERIA

. Age >18 years

.

Exclusion criteria:

Established ESRD

Age less than 18yrs

Death within 1day of admission

Discharge against medical advice

Patients on haemodialysis

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Plan for data analysis: Data will be entered in Microsoft Excel sheet and will be analysed

using SPSS version 11.0 statistical software. Data will be depicted in the form of tables and

charts. Appropriate statistical tests like Chi Square test and other non parametric tests will be

used.

7.3 Does the study require any investigations or interventions to be

conducted on patients or other humans or animals? If so, please describe

briefly.

Yes,

• Complete blood count

• Blood Urea and serum Creatinine

• Uric acid

• Peripheral smear

• Platelet count

• Urine analysis

• Ultrasound abdomen

• Serum electrolytes

• Serum calcium level

AS AND WHEN REQUIRED

• Liver function test

• 24hr urine protein

• Urine culture and sensit ivity

• Blood culture and sensit ivity

• MPFT, WIDAL test

• Dengue and Leptospirosis serology

• Fundus examination

• Chest X-RAY

• Echocardiogram

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• Serum Phosphorous

• PT, aPTT

• Renal biopsy

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

yes

8. References:

• Metha RL,kallum, JR,Shah SV. at al. acute kidney injury network, report on initiation to improve outcome in acute kidney injury. Crit care 2007;11:R31.

• Liu KD, Cherton GM. Acute renal failure: Fauci, Baunwald, Kasper, editors, Harrison’s principles of internal medicine 17th ed, New york: McGraw-Hill: 2008. p1752-1761.

• Lokesh LV , Chandrashekar P ,Mahesh E,Kota R, Clinical profile of acute renal failure in intensive care unit (ICU).JAPI 2009 DECEMBER VOL 78: 456-459.

• Sean M.Bagshaw, Hiroshi Morimatsu, Noel Gibney, Ashita tolwani, Miet Schetz, Ian Tan et al. acute kidney injury in critically ill patients: Clinical characteristics ans outcomes. CJASN MAY 2007 vol 2: 431-439.

• Prakash j, murthyAS , Vohra R , Rajak M, Mathur SK. Acute renal failure in intensive care unit(ICU). JAPI 2006 VOL 54:PAGE 724-728.

• Shigehiko Uchino, Ettiene Macedo, John A.Kellum, Catherine Bouman , Stanislao Morgera , Gordon S. Doig et al. Acute renal failure in critically ill pateients . JAMA 2005:294(7):813-818.

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9. Signature of the candidate :

10. Remarks of the guide:

11. Name and Designation of (in block letters):-

11.1 Guide:

11.2 Signature

11.3 co-Guide: Dr. RAGHAVENDRA NAYAK MD, DNB

DEPT.OF NEPHROLOGY

11.5 Signature

11.3 Head of Department:

11.4 Signature:

12. Remarks of the Chairman and Principal:

12.2Signature:

13

Dr. EVS MABEN M.D.

PROFESSOR & HEAD

DEPT.OF MEDICINEA.J. INSTITUTE OF MEDICAL SCIENCES

Dr. GANESHA KUMARA KHANDIGE M.D.

PROFESSOR

DEPT.OF MEDICINE A. J. INSTITUTE OF MEDICAL SCIENCES

PROFORMAA STUDY OF ETIOLOGY, CLINICAL PROFILE AND PROGNOSIS OF PATIENTS WITH ACUTE

KIDNEY INJURY FORMAT OF PATIENT EXAMINATION

1. Case No. 2. I.P No.

3. Patient’s Name 4. Age

5. Gender - 6. Occupation

7. Address

CHIEF COMPLAINTS

HISTORY OF PRESENTING ILLNES

PAST HISTORY

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FAMILY HISTORY

PERSONAL HISTORY

GENERAL EXAMINATION :

State of nutrition & built

Pallor / Icterus / Clubbing / Cyanosis / Edema / Lymphadenopathy

BP : RR:PR : patient on oxygen/ventilator/NIVUrine input and output

EXAMINATION OF ABDOMEN :

EXAMINATION OF RESPIRATORY SYSTEM :

EXAMINATION OF CARDIOVASCULAR SYSTEM :

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EXAMINATION OF CENTRAL NERVOUS SYSTEM :

INVESTIGATIONS

Data collection table:

Complete blood count

Blood Urea

Serum Creatinine

Peripheral smear

Platelet count

Urine analysis

Ultrasound abdomen

Uric acid

Serum calcium

Serum Electrolytes

16

AS AND WHEN REQUIRED

Liver function test

24 hour urine protein

Blood culture and sensitivity

Urine culture and sensitivity

MPFT

WIDAL test

Dengue Serology

Leptospirosis Serology

Fundus examination

Chest X-RAY

Echocardiogram

Serum phosphorous

PT, Aptt

Renal biopsy

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Written Informed Consent Form

A J INSTITUTE OF MEDICAL SCIENCES, KUNTIKANA, MANGALORE.

Informed consent form for the volunteers at “A J Institute of Medical Sciences,

Kuntikana, Mangalore”, who will be participating in the research project (MD

dissertation) entitled : “ A STUDY OF ETIOLOGY, CLINICAL PROFILE

AND PROGNOSIS IN PATIENTS WITH ACUTE KIDNEY INJURY”

Name of Principal Investigator Dr.B.M.Murthy,

Postgraduate student

Name of Organization Department of Medicine,

A.J.Institute of Medical Sciences,

Kuntikana, Mangalore

This Informed Consent Form has two parts:

Information Sheet (to share information about the research with you)

Certificate of Consent (for signatures if you agree to take part)

You will be given a copy of the full Informed Consent Form

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PART I: Information Sheet

Introduction

I, Dr.B.M.Murthy, postgraduate student in the Department of Medicine, A J Institute of Medical Sciences, Kuntikana, Mangalore, am working on my MD dissertation titled “A STUDY OF ETIOLOGY, CLINICAL PROFILE AND PROGNOSIS IN PATIENTS WITH ACUTE KIDNEY INJURY”.

I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research.

There may be some words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have questions later, you can ask them and get yourself clarified.

Purpose of the research

• To identify cause of AKI in patients admitted in AJIMS.

• To determine the risk factors, prognosis and outcome of AKI in patients admitted in AJIMS

Type of Research Intervention

Patients’ blood or urine sample or both sent for investigation and non invasive investigation LIKE ultrasound abdomen will be done to know cause for acute kidney injury in patients admitted in AJIMS

Participant selection

Patients admitted in AJIMS, who comes under AKIN CRITERIA

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Procedures and ProtocolAll the patients who fulfill AKIN criteria depending upon serum creatinine levels will further undergo other investigations, sometimes we need to do renal biopsy to determine the cause and prognosis of the condition. All the patients will be followed up for 1 year.

Voluntary Participation

Your participation in this research is entirely voluntary. It is your choice whether to participate or not. Whether you choose to participate or not, it will not affect your treatment process.

Benefits Personally you might be or may not be benefited in any way directly from the research. But by taking part in this research, you will be helping the scientific community to learn more about the etiology, clinical profile and prognosis of acute kidney injury

Reimbursements

You won’t be given any monetary incentives or gifts for being a part of this research.

Confidentiality

The information that we collect from this research project will be kept confidential. Information about the patient that will be collected during the research will be put away and no-one but the researchers will be able to see it. Any information about the patient will have a number on it instead of your name.

Sharing the Results

The knowledge that we get from doing this research will be shared with you. Confidential information will not be shared. We will publish the results in order that other interested people may learn from our research.

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Right to Refuse or Withdraw

You do not have to take part in this research if you do not wish to do so. You may also stop participating in the research at any time you choose. It is your choice and all of your rights will still be respected.

Who to Contact

This proposal has been reviewed and approved by the Research and Ethical committee of A J institute of Medical Science, Kuntikana Mangalore, which is a committee whose task it is to make sure that research participants are protected from harm. You may contact the following member of the Institute Ethics committee for more details

Dr. B M Murthy

Dr. Ganesha Kumara Khandige

You can ask me any more questions about any part of the research study, if you wish to. Do you have any questions?

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PART II: Certificate of Consent

I have read the foregoing information, or it has been read to me. I have had the

opportunity to ask questions about it and any questions that I have asked have

been answered to my satisfaction. I consent voluntarily to participate as a

participant in this research.

Name of Participant_________________________

Signature of Participant ___________________

Date __________________________________

Day/month/year

If illiterate a literate witness must sign (if possible, this person should be

selected by the participant and should have no connection to the research

team). Participants who are illiterate should include their thumb-print as well.

I have witnessed the accurate reading of the consent form to the potential

participant, and the individual has had the opportunity to ask questions. I

confirm that the individual has given consent freely.

Name of witness_________________ Thumb print of participant

Signature of witness _____________

Date ________________________

Day/month/year

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Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and

to the best of my ability made sure that the participant understands that the

following will be done:• Complete blood count

• Blood urea and serum creatinine

• Uric acid

• Peripheral smear

• Platelet count

• Urine analysis

• Ultrasound Abdomen for all patients

• Serum electrolytes

• Serum calcium level

AS AND WHEN REQUIRED

• Liver function test

• 24hr urine protein.

• Blood culture and sensitivity

• Urine culture and sensitivity

• Serum phosphorous

• MPFT

• Widal test

• Dengue Serology

• Leptospirosis Serology

• Fundus examination

• Chest X-RAY

• Echocardiogram

• PT, aPTT• Renal biopsy

23

I confirm that the participant was given an opportunity to ask questions about

the study, and all the questions asked by the participant have been answered

correctly and to the best of my ability. I confirm that the individual has not been

coerced into giving consent, and the consent has been given freely and

voluntarily.

  

 A copy of this informed consent form has been provided to the participant.

Name of Researcher/person taking the consent________________________

Signature of Researcher /person taking the consent_____________________

Date ___________________________

Day/month/year

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