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CTRI Number  CTRI/2024/12/078748 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 25/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   “Impact of acute kidney injury (AKI) according to KDIGO staging criteria on survival in ICU patients” 
Scientific Title of Study   Impact of acute kidney injury (AKI) according to KDIGO staging criteria on 28-day mortality in critically ill patients: a prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kshitija Kulshrestha 
Designation  DrNB resident, Critical care medicine 
Affiliation  BLK MAX Superspeciality Hospital, New Delhi 
Address  Department of Critical Care Medicine, BLK-MAX Superspeciality Hospital, Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi

New Delhi
DELHI
110005
India 
Phone  7038896834  
Fax    
Email  kshitijakul@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jitin Sharma 
Designation  Principal consultant, Critical care medicine 
Affiliation  BLK MAX Superspeciality Hospital, New Delhi 
Address  Department of Critical Care Medicine, BLK-MAX Superspeciality Hospital, Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi

New Delhi
DELHI
110005
India 
Phone  8800287026  
Fax    
Email  jitin.sharma@blkmaxhospital.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kshitija Kulshrestha 
Designation  DrNB resident, Critical care medicine 
Affiliation  BLK MAX Superspeciality Hospital, New Delhi 
Address  Department of Critical Care Medicine, BLK-AX Superspeciality Hospital, Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi

New Delhi
DELHI
110005
India 
Phone  7038896834  
Fax    
Email  kshitijakul@yahoo.co.in  
 
Source of Monetary or Material Support  
BLK-MAX Superspeciality Hospital, Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi, 110005 
 
Primary Sponsor  
Name  N/A 
Address  N/A 
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 
Dr Kshitija Kulshrestha  BLK-MAX Superspeciality hospital, Delhi  Department of critical care medicine, BLK-MAX Superspeciality Hospital, Pusa Rd, Radha Soami Satsang, Rajendra Place, New Delhi, Delhi, 110005
Central
DELHI 
07038896834

kshitijakul@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. B. L. Kapur Memorial Hospital Ethics Commitee  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Patients who have acute kidney injury on ICU admission or develop acute kidney injury during ICU stay  
 
ExclusionCriteria 
Details  1.Pregnant patients
2.Patients with chronic kidney disease
3.Patients with renal or liver transplant
4.Terminally ill patients e.g., those suffering from advanced cancer
5.Mortality within 48 hours of ICU admission
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mortality  28 day 
 
Secondary Outcome  
Outcome  TimePoints 
Requirement of renal replacement therapy
 
hospital discharge/ mortality 
Length of ICU & hospital stay  hospital discharge/ mortality 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   06/01/2025 
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   N/A 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  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 [kshitijakul@yahoo.co.in].

  6. For how long will this data be available start date provided 02-12-2026 and end date provided 02-03-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Acute kidney injury is one of the most common organ impairments seen in intensive care units. An estimated 7.5% of hospitalized population in South Asia develops AKI. The incidence is much higher in ICU patients, varying from 1 in 3 to 2 in 3, based on the diagnostic criteria used. Acute kidney injury is a concern for physicians given its association with increased length of ICU stay, health care costs and in-hospital mortality in short term to increased risks of cardiovascular events, progression to chronic kidney disease, and long-term mortality. A strong and graded relationship between AKI severity and increased mortality has been established. 

Given the significance of AKI on patient outcome, Risk, Injury, Failure, Loss, End-Stage (RIFLE) criteria by Acute Dialysis Quality Initiative (ADQI) and later, updated Acute Kidney Injury Network (AKIN) criteria aimed to define and stage AKI. In 2012, Kidney Disease Improving Global Outcomes (KDIGO) staging system was introduced which combined the previous 2 systems and is currently the recommended system. These systems rely on three diagnostic criteria: a rise in serum creatinine (SCr), a decrease in urine output (UO), and administration of renal replacement therapy (RRT), to define AKI into various stages.

 However, it has been observed in various studies that KDIGO criteria do not encompass all the factors that adversely affect patients with AKI. Additionally, categorization of severity of AKI using KDIGO criteria may not always be accurate.

 We plan to perform a prospective observational study on impact of AKI severity & other patient and disease related factors on mortality, in critically ill patients.

 
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