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CTRI Number  CTRI/2021/11/037925 [Registered on: 10/11/2021] Trial Registered Prospectively
Last Modified On: 07/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   risk factors for infection associated kidney damage in icu patients 
Scientific Title of Study   risk factors for sepsis associated acute kidney injury in adults admitted to icu 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Girish kumar J 
Designation  Pg student , Dnb superspeciality in critical care medicine  
Affiliation  Gangaram hospitals  
Address  Sir gangaram hospital,Department of critical care and emergency medicine, 4th floor,ssrb block, new delhi
Sir gangaram hospital, department of critical care and emergency medicine, 4 floor ssrb new delhi
New Delhi
DELHI
110060
India 
Phone  01142252451  
Fax    
Email  mailtogirishj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Girish kumar J 
Designation  Pg student , Dnb superspeciality in critical care medicine  
Affiliation  Sir gangaram hospital  
Address  Sir gangaram hospital, dept of critical care emerge medicine,4th floor,ssrb block, new delhi
Sir gangaram hospital, department of critical care and emergency medicine, 4 floor, ssrb block, new delhi
New Delhi
DELHI
110060
India 
Phone  01142252451  
Fax    
Email  mailtogirishj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Girish kumar J 
Designation  Pg student , Dnb superspeciality in critical care medicine  
Affiliation  Sir gangaram hospital  
Address  Sir gangaram hospital, dept of criticalcare and emergency medicine, 4th floor,ssrb block, new delhi
Sir gangaram hospital, department of critical care and emergency medicine. 4 floor ,ssrb block
Central
DELHI
110060
India 
Phone  01142252451  
Fax    
Email  mailtogirishj@gmail.com  
 
Source of Monetary or Material Support  
material support from sir ganga ram hospital 
 
Primary Sponsor  
Name  sir ganga ram hospital 
Address  central delhi new delhi 
Type of Sponsor  Private hospital/clinic 
 
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 
dr prakash shastri  icu, sir ganga ram hospital  Room no 2400,4th floor,ssrb block sir ganga ram hospital
Central
DELHI 
9810937295

prakashshastri@live.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee  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  all adult icu patients developing aki in sepsis 
 
ExclusionCriteria 
Details  ckd receiving dialysis
organ donor or transplant patients
pre existing aki at the onset of shock 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Risk factors associated SA-AKI  90 days  
 
Secondary Outcome  
Outcome  TimePoints 
resolution of AKI
ICU and hospital length of stay
Development of CKD by 90 days
In hospital and 90 day mortality 
90 days from the icu admission
untilresolution of aki
 
 
Target Sample Size   Total Sample Size="156"
Sample Size from India="156" 
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   Phase 1 
Date of First Enrollment (India)   10/11/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
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 - Informed Consent Form
    Response - Clinical Study Report

  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 [mailtogirishj@gmail.com].

  6. For how long will this data be available start date provided 23-12-2022 and end date provided 23-11-2028?
    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  

Sepsis associated acute kidney injury is a syndrome of acute loss of renal function, defined by the simultaneous presence of both Sepsis and renal dysfunction as per KDIGO criteria. Severe sepsis and septic shock are the main causes of acute kidney injury (AKI) in the intensive care unit (ICU). The treatment of AKI is supportive. No generally accepted guidelines for indication or optimal timing for initiation of renal replacement therapy (RRT) exist. Apart from life-threatening indications, the initiation of RRT is mainly based on clinical judgment.The long-term mortality of hospital survivors with AKI remains increased for several years after critical illness. Risk and outcomes for sepsis associated AKI in adult patients admitted to ICU has not been systematically evaluated. The objectives of this study is to assess the association of risk factors and outcome of ICU patients with sepsis associated AKI.

All consecutive adults admitted to ICU with suspected infection, along with SOFA score >6 or acute increase in SOFA score by >2 or culture positive sepsis will be enrolled. We will use KDIGO criteria to define AKI during ICU stay. The enrolled patients will be followed till ICU/Hospital discharge, ICU or hospital mortality, resolution of AKI, death or survival at day 90 from entry, and for long term outcome of the development of chronic kidney disease. We will collect data on multiple variables and risk factors.

 
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