Department of MEDICINE

Indira Gandhi Govt. Medical College, Nagpur.

Date: August, 2018

To,
The Chairman,
Institutional Ethics Committee,
IGGMC, Nagpur.

Through the proper channels

Subject :- Submission of application for approval of Title & Synopsis of Dissertation/
ICMR-STS

Respected sir,
I, the undersigned, Dr Reshma Abraham, a post graduate student
in the department of medicine at IGGMC, Nagpur admitted in academic year
2016-2017
I am submitting an application in prescribed format(3 hard copies &
one soft copy CD)along with necessary annexure for the approval of the
dissertation / thesis entitled
Clinical profile of acute kidney injury in a tertiary care centre

Name of the PG Guide: Dr.Shobana Amol Bittey,

Associate professor
Dept. of medicine ,
IGGMCH , Nagpur.

Thanking you
Yours faithfully,
Dr.Reshma Abraham
PG student,
Dept. of medicine
IGGMCH , Nagpur
 INDIRA GANDHI GOVT. MEDICAL COLLEGE, NAGPUR.

PROFORMA FOR SUBMISSION OF RESEARCH PROJECT / DISSERTATION

1. Name of the Principal Investigator: Dr Reshma Abraham,

2. Name & Designation of the
Co-investigator/s/ P.G. guide
Post Graduate Student
Dept. of medicine,
IGGMC, Nagpur.
: Dr.Shobana Amol Bittey,
Associate professor
Dept. of medicine,
IGGMC, Nagpur.

3. Title of the research project” Clinical profile of acute kidney injury in a

tertiary care centre”

4. i) Signature of Principal Investigator/

P.G. Student

ii) Signature/s of co-investigator/s/

P.G. Guide

iii) Signature of Professor and Head

Of Dept. (with seal)

iv) Signature of the Head/s of the

Other Depts. Involved (with seal)
 APPENDIX A
(FORMAT FOR SUBMISSION OF TOPIC BY P.G. STUDENT
Date: August 2018

Name of the Indira Gandhi Government Medical college, Nagpur

College:

Department Department of General Medicine

Name of Guide & Dr. Shobana Amol Bittey

College Name
Indira Gandhi Government Medical college, Nagpur

Contact Number of 9763959225

Guide

Through the proper channel

To,
The Registrar
MUHS,
Nashik- 422004

Subject: Submission of title & Synopsis of Dissertation.

Respected Sir/Madam,
I, the undersigned Dr Reshma Abraham, registered for MD general medicine in the year
2018-19 batch under the guidance of , Dr. Shobana Amol Bittey,Associate professor, Dept. of
general medicine, IGGMCH , Nagpur. I am due to appear for MD general medicine in April –
May 2021.
I am submitting herewith Title & Synopsis of Dissertation as topic as mentioned below &
as suggested by my aforesaid Guide.
Title of Synopsis :
” CLINICAL PROFILE OF ACUTE KIDNEY INJURY IN A TERTIARY
CARE CENTRE”
Kindly accept and register my Title of Synopsis.

Dr Reshma Abraham
The Qualification of the teacher is recognised by the Central Council
Dr. Shobana Amol Bittey, Dr. P. P.
Joshi,
Dept. of Medicine, Dept. of Medicine,
IGGMC, Nagpur. IGGMC, Nagpur.

Signature & Seal of Dean of College

REPORT OF ETHICS COMMITTEE

Department GENERAL MEDICINE

Candidate admitted year 2016-17
Course and subject: GENERAL MEDICINE
College name and address Indira Gandhi Govt. Medical College, Nagpur

Date: NOVEMBER 2016

Ref. No.:
To,

Dr.Reshma Abraham,
Dept. of MEDICINE,
IGGMC and Hospital,
Nagpur.

Subject: Regarding your research proposal of dissertation topic,

entitled:“ Clinical profile of acute kidney injury in a tertiary care

centre”

(Letter proposal of student)

Dear student,
The above mentioned research proposal of dissertation topic was discussed in the
Ethics committee meeting held on _____________ at our college.
Ethics committee has unanimously approved your dissertation topic. This work will
be done under the guidance and supervision of your guide Dr.Shobana Amol Bittey,
Department of medicine, IGGMC, Nagpur.

Signature .
 INSTITUTIONAL ETHICS COMMITTEE
INDIRA GANDHI GOVT. MEDICAL COLLEGE, NAGPUR.

Name of PG student/ research fellow: Dr. Reshma Abraham,

Department : Department of medicine, IGGMC, Nagpur

Topic : “”Clinical profile of acute kidney injury in a tertiary care

centre”

Remarks of Ethical Committee :

Status: Approved/Resubmission :

Member Member Member Member

 Member Member Member Member

Member Secretary Chairman

To,
The Chairman,
Ethics Committee,
IGGMC, Nagpur.

Subject : Cost bearing of Investigation of the patients participating in the thesis trial.

Respected sir,

I the undersigned Dr. Reshma Abraham, JR1 Dept. of General medicine

Study Title:
“Clinical profile of acute kidney injury in a tertiary care centre”

My P.G guide is Dr.Shobana Amol Bittey, Department of General Medicine, Indira

Gandhi Govt. Medical College, Nagpur.

I want to assure you that the additional cost of all investigation if any will be done by
the investigator Dr.Reshma Abraham,
 So kindly consider my application for the same.

Thanking you.
Yours obediently Dr.
Jambhulkar Prakash Kundlik ,
Post Graduate Student,
Dept. of medicine
IGGMC, Nagpur.

ETHICAL COMMITTEE PROFORMA

PART II

TITLE OF DISSERTATION

“Clinical profile of acute kidney injury in a tertiary

care centre”
PRINCIPAL INVESTIGATOR: DR Reshma Abraham
PG student,
Dept. of Medicine,
IGGMC and Hospital,
Nagpur.

PG GUIDE: DR. shobana amol bittey

Dept. of medicine,
IGGMCH, Nagpur.

INTRODUCTION
(A) NEED FOR STUDY:
(B) Acute kidney injury is one of the most common conditions seen in a tertiary care
centre
(C) We come across acute kidney injury in patients on admission initially, or as a
development during the course of the disease, as a complication.
(D) Much of the available data on clinical course of patients with ARF is from western
literature.
(E) Compared to the western literature, reports from our country are scanty.
Also, the need for the present study in IGGMC is becoming increasingly important as the
number of cases of acute kidney injury is building up and the study regarding AKI in
Nagpur are limited. ) OBJECTIVES OF THE STUDY
To study the clinical and etiologcal profile of acute kidney injury in a tertiary care.

To study the impact of acute kidney injury on the disease and outcome of
patients with acute kidney injury
(3) REVIEW OF LITERATURE:

The criteria used for the diagnosis of acute kidney injury is the RIFLE criteria.

Risk- Increased S.creatinine x 1.5/ urine output<0.5ml/kg/hr x 6hrs.

Or GFR decrease > 25%
Injury- Increased S.creatinine x 2 / urine output<0.5ml/kg/hr x 12hrs
Or GFR decrease > 50%
Failure-Increased S.creatinine x 3 or S.creatinine >4mg/dl or acute rise
>0.5 mg/dl.
Or GFR decrease > 75%
OR
Urine output < 0.3ml/kg/hr x 24hrs, or anuria x 12

Bellomo R, Ronco C and the ADQI group developed a consensus for defining ARF, being the RIFLE (Risk,
Injury, Failure, Loss and End stage). They concluded that despite limited data, broad areas of consensus
exist for defining ARF, selection of animal models, methods of monitoring fluid therapy, choice of
physiological and clinical end-points for trials, and the possible role of information technology.4

Bagshaw S.M, George Carol and others conducted a multi-centre study of critically ill patients using the
RIFLE criteria. They concluded that the RIFLE criteria represent a simple tool for the detection and
classification of AKI and for correlation with clinical outcomes.5

Ritesh Varnekar and Vikram Prabha assessed acute renal failure in hospitalised patients in Belgaum and
concluded that patients of the failure group had a higher APACHE II score, almost none of the risk/injury
group needed renal replacement therapy and mortality was more in the ICU group and the percentage
of patients in the ICU needing renal replacement therapy was higher than the non-ICU group.7

Brivet, Francois G, Kleinknecht and others conducted a prospective study comprising of twenty French
multidisciplinary intensive care units. Their study showed that the major causes of AKI were due to
sepsis, followed by hemodynamic alterations, nephrotoxin administrations and prerenal factors, in
decreasing order.8

Louise Cole, Rinaldo Bellomo et al conducted a prospective, multicenter study of severe acute renal
failure in a ‘closed’ ICU system. Among the 116 patients admitted to the ICUs, it was noted that the
majority were associated with severe sepsis/ septic shock. Other major triggers were cardiothoracic
surgery, and myocardial pump failure. It was also noted that main reason for starting renal replacement
therapy was severe and persistent oliguria or anuria in the majority.9

Ravindra L Mehta, Maria T. Pascual, Sharon Soroko et al were involved in the Program to Improve Care
in Acute Renal Disease (PICARD), prospective observational cohort study in the ICUs at 5 academic
medical centres in the United States. In the study they noted that there was extensive co morbidity
associated with acute renal failure; the main being coronary artery disease, followed by diabetes
mellitus and chronic liver disease. The conclusion was that there is a changing spectrum of ARF in the
critically ill, characterised by a large burden of comorbid disease and extensive extrarenal
complications.10

J Prakash, AS Murthy, R Vohra et al, studied acute renal failure in the intensive care unit in Banaras
Hindu University between September 2003 to January 2005. They noted that ARF was seen in 3.79% of
cases in ICU of BHU and was associated with a poor prognosis. Presence of sepsis, MODS, higher
APACHE- III scores and ventilation needed for the patients were correlated with higher mortality in ARF
patients in the ICU setup.11

3.RESEARCH PROTOCOL/MATERIALS AND METHODS

SOURCE OF DATA:

All patients admitted in the medicine wards of Indira Gandhi government

medical college,Nagpur.
Type of Study: A Prospective study design.

INCLUSION CRITERIA

1. Patients who fulfill the RIFLE criteria for Acute kidney disease
(Risk, injury, failure).

Risk- Increased S.creatinine x 1.5/ Urine output<0.5ml/kg/hr x 6hours.

Injury- Increased S.creatinine x 2 / Urine output <0.5ml/kg/hr x 12hours

Failure- Increased S.creatinine x 3 or S.creatinine >4mg/dl or acute rise

>0.5 mg/dl.

OR

Urine output < 0.3ml/kg/hr x 24hours, or anuria x 12hours

2. Minimum of 24 hours of admission

EXCLUSION CRITERIA:

1. Patients of established Chronic Kidney Disease and end stage

renal disease.

2. Prerenal factors like volume depletion which is correctable within

48 hours.

3. Age < 18 years.

4. Discharge against medical advice.

5. Deaths within one day of admission

 METHODS OF COLLECTION OF DATA:

All the patients admitted in the intensive care unit of our hospital during the
period of , who are fitting into the inclusion criteria will
be taken into the study

Statistical method

Descriptive statistical characteristics and variables of the patients will be

described.

The biochemical and other numerical parameters can be compared

between survivors and fatal cases using t test, ANOVA test.

Intervention:-none
 Does the study require any investigations or interventions to be conducted on patients or
other humans or animals? If so, please describe briefly.

YES (As and when required)

Complete urine examination, 24 hour urine protein estimation, urine albumin.
Hematology, Biochemistry-
Complete hemogram- including Hb, total count, platelets.
Blood urea, serum creatinine, serum electrolytes, RBS
Liver function tests
Urine routine
Serum calcium, phosphorus,
Coagulation profile,
Microbiological tests like bacterial and fungal (in patients with indication)cultures of blood,
urine,
venous catheters, wound and endotracheal secretions.
Malaria test, Widal test, Weil-Felix, dengue serology
Radiological tests include x-ray of chest and abdomen and ultrasonography/computer
tomography (CT)
of abdomen and pelvis.
2D ECHO
HIV, HBs Ag, HCV
Ophthalmology- Fundoscopy.
Renal biopsy
Other relevant investigations
Has ethical clearance been obtained from ethical committee of your institution in case of

. LIST OF REFERENCES:

1. Ronco C, Bellomo R, Kellum JA. The concept of acute kidney injury and the rifle
criteria. Acute Kidney Injury. Contrib Nephrol. Basel, Karger. 2007; 156: 10-16.

2. Clarkson MR, Friedewald JJ, Eustace JA, Rabb H. Acute Kidney Injury: Brenner BM.
Brenner and Rector’s- The Kidney, 8th ed. Philadelphia: Saunders- Elsevier; 2008. p943-
986.

3. Kavaz A, Ozcakar B, Kendirli T, Ozturk B, Ekim M, Yalcinkaya F. Acute kidney injury

in a pediatric intensive care unit: comparison of pRIFLE and AKIN criteria. Foundation
Acta Paediatrica. 2012; 101: e126-e129.

4. Srivastava R, Bagga A. Pediatric nephrology. In: Srivastava R, Bagga A. Acute kidney

injury: Jaypee 5th edition; 2011. p 235-260.

5. Cerda J, Lamiere N, Pannu N, Uchino S, Wang H, Bagga A et al. Epidemiology of acute

kidney injury. Clin J AM Soc Nephrol. 2008; 3:881-886.

6. Krishnamurthy S, Mondal N, Narayanan P, Biswal N, Srinivasan S, Soundravally R.

Incidence and etiology of acute kidney injury in southern india. Indian J Pediatr. 2012
Jun 14. [Epub ahead of print]. DOI 10.1007/s12098-012-0791-z.

7. Mehta P, Sinha A, Sami A, Hari P, Gulati A, Bagga A et al. Incidence of acute kidney
injury in hospitalized children. Indian Pediatr. 2012; 49(7): 537-42.

8. Bailey D, Phan V, Litalien C, Ducruet T, Merouani A, Lacroix J et al. Risk factors of

acute renal failure in critically ill children: a prospective descriptive epidemiology study.
Pediatr Crit Care Med. 2007; 8: 29-35.
 9. Akcan-Arikan A, Zappitelli M, Loftis LL, Washburn KK, Jefferson LS, Goldstein SL.
Modified RIFLE criteria in critically ill children with acute kidney injury. Kidney Int.
2007; 71: 1028-35.

10. North East Italian Prospective Hospital Renal Outcome Survey on Acute Kidney Injury
(NEiPHROS-AKI) Investigators, Cruz DN, Bolgan I, Perazella MA, Bonello M, de Cal
M, et al. North East Italian Prospective Hospital Renal Outcome Survey on Acute Kidney
Injury (NEiPHROS-AKI): Targeting the problem with the RIFLE Criteria. Clin J Am Soc
Nephrol. 2007; 2: 418-25.

11. Zappitelli M, Moffett BS, Hyder A, Goldstein SL. Acute kidney injury in non-critically
ill children treated with aminoglycoside antibiotics in a tertiary healthcare centre: a
retrospective cohort study. Nephrol Dial Transplant. 2011; 26: 144–50.

PROFORMA

NAME

AGE

SEX

IP NO

COMORBID ILLNESS

DM

SHT

CAD

CLD

PRESENTED/DEVELOPED KIDNEY INJURY

OLIGURIA

ETILOGY OF AKI
(F)