FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036355 [Registered on: 08/09/2021] Trial Registered Prospectively
Last Modified On: 07/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   INCIDENCE OF ACUTE KIDNEY INJURY IN PATIENT ADMITTED TO MEDICAL INTENSIVE CARE  
Scientific Title of Study   INCIDENCE OF ACUTE KIDNEY INJURY IN PATIENT ADMITTED TO MEDICAL ICU PROSPECTIVE OBSERVATIONAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR AMOL PARATE 
Designation  SENIOR RESIDENT CCM 
Affiliation  FORTIS ESCORTS HEART INSTITUTE  
Address  DEPARTMENT OF CRITICAL CARE MEDICINE GROUND FLOOR FORTIS ESCORTS HEART INSTITUTE OKHLA DELHI 110024

South West
DELHI
110024
India 
Phone    
Fax    
Email  amolparate8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR RAJAT AGRAWAL 
Designation  HOD & ADDITIONAL DIRECTOR CRITICAL CARE MEDICINE 
Affiliation  FORTIS ESCORTS HEART INSTITUTE  
Address  DEPARTMENT OF CRITICAL CARE MEDICINE GROUND FLOOR FORTIS ESCORTS HEART INSTITUTE OKHLA

New Delhi
DELHI
110024
India 
Phone    
Fax    
Email  Rajat.agarawal@fortishealthcare.com  
 
Details of Contact Person
Public Query  
Name  DR AMOL PARATE 
Designation  SENIOR RESIDENT CCM 
Affiliation  FORTIS ESCORTS HEART INSTITUTE  
Address  DEPARTMENT OF CRITICAL CARE MEDICINE GROUND FLOOR FORTIS ESCORTS HEART INSTITUTE OKHLA

New Delhi
DELHI
110024
India 
Phone    
Fax    
Email  Amolparate8@gmail.com  
 
Source of Monetary or Material Support  
Fortis escorts heart institute okhla New Delhi  
 
Primary Sponsor  
Name  Fortis Escorts Heart Institute 
Address  Fortis Escort Heart Institute Okhla New Delhi110024 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Amol parate  Fortis escorts heart institute okhla New Delhi   Department of Critical care medicine ground floor
New Delhi
DELHI 		 9404299739

amolparate8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FEHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N179||Acute kidney failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patient ahe between 18-75 years
2. All patient admitted in medical icu with baseline normal creatinine
3. Patient or legal representative giving written informed consent 
 
ExclusionCriteria 
Details  1. Patient under 18 years or above 75 years of age
2. Undergoing any kind of RRT
3. Undergoing kidney transplant
4. Pregnant patient
5. Anticipated length of stay in icu less than 24 hours
6. Readmission in the icu during study period 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Incidence of acute kidney injury in medical icu
2. Risk factors responsible for acute kidney injury 		 Upto 7 days or till discharge from ICU  
 
Secondary Outcome  
Outcome  TimePoints 
Numbers of patient requiring Renal Replacement therapy after acute kidney injury   Upto 7 days or till discharge from icu 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [amolparate8@gmail.com].

  6. For how long will this data be available start date provided 21-07-2021 and end date provided 07-07-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   It’s a prospective observational study of incidence of acute kidney injury patients admitted to medical icu in Indian set up 
Close