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CTRI Number  CTRI/2025/11/097466 [Registered on: 14/11/2025] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study to find out which factors help critically ill patients recover enough to stop kidney support (dialysis) in the ICU 
Scientific Title of Study   Factors Associated With Successful Liberation From Continuous Renal Replacement Therapy 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  Satish Patel 
Designation  Senior Resident (D.M. Critical Care Medicine) 
Affiliation  AIIMS Raipur 
Address  Critical Care Unit Dept. of Anaesthesiology and Critical Care AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9871929904  
Fax    
Email  doc.satish.patel@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Subrata Singha 
Designation  Professor and Head of Department 
Affiliation  AIIMS Raipur 
Address  Dept. of Anaesthesiology and Critical Care AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9871929904  
Fax    
Email  icutrauma@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  Satish Patel 
Designation  Senior Resident (D.M. Critical Care Medicine) 
Affiliation  AIIMS Raipur 
Address  Critical Care Unit Dept. of Anaesthesiology and Critical Care AIIMS Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9871929904  
Fax    
Email  doc.satish.patel@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Raipur GE road, Tatibandh, Raipur, Chhattisgarh, India 492099  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Raipur 
Address  All India Institute of Medical Sciences Raipur, GE road, Tatibandh, Raipur, Chhattisgarh, India 492099 
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 Satish Patel  All India Institute of Medical Sciences Raipur  Critical Care Unit 2nd Floor,Trauma Building Dept. of Anaesthesiology and Critical Care
Raipur
CHHATTISGARH 		 9871929904

doc.satish.patel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee AIIMS Raipur  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Acute Kidney Injury
Acute on Chronic Kidney Disease
Hemodynamic Instability 
 
ExclusionCriteria 
Details  CONCURRENT ECMO
CRRT FOR DIFFERENT PRIMARY INDICATION(EG. ACUTE LIVER FAILURE, INTOXICATION)
H/O RENAL TRANSPLANT
MORTALITY WITHIN 24 HOUR OF CRRT 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assesss the association between fluid balance gap % and liberation from CRRT  every day from the start of CRRT till the patient is on CRRT 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the association between Vasoactive ionotropic score & liberation from CRRT  every day from the start of CRRT till the patient is on CRRT 
To study the association between disease severity measured by SOFA & APACHE-2 on admission,CRRT initiation & liberation from CRRT  every day from the start of CRRT till the patient is on CRRT 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   24/11/2025 
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="6"
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  data will be available, when published in any journal

  6. For how long will this data be available start date provided 22-04-2025 and end date provided 01-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
The study will be started after obtaining approval from Institute Ethics Committee
(IEC). Written and informed consent will be obtained. Patients planned for CRRT
will be enrolled after fulfilling inclusion criteria and their demographic data,
comorbidities, diagnosis, Acute Physiology and Chronic Health Evaluation
(APACHE II) score on critical care unit admission, Sequential Organ Failure
Assessment (SOFA) score on admission will be noted. Also their on admission
vitals, ABG and renal parameters (urea, creatinine, creatinine clearance, and urine
output) will be recorded.
The SOFA score, vitals, ABG parameters, Renal parameters and cumulative fluid
balance will be noted on CRRT initiation and liberation. Also VIS maximum in
the last 24 hours before initiating CRRT and at the time of CRRT liberation will
be recorded
On CRRT daily FB goal, FB achieved and FB gap % will be recorded till the time
patient is on CRRT. Time duration from AKI to CRRT initiation and total duration
of CRRT will also be recorded.
The patient will be liberated from CRRT based on clinical judgment and if
following criteria met
Creatinine clearance > 15 ml/minute
Spontaneous urine output > 500 ml/day
Hemodynamic stability
The whole data will be compared among patients successfully liberated from
CRRT and CRRT reinstituted group for any statistical significance.
 
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