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CTRI Number  CTRI/2024/04/065063 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Renal Replacement Therapy Practices in acute kidney injury patients in Indian ICUs (pracRRT Study) 
Scientific Title of Study   Prospective observational study of Renal Replacement Therapy Practices in acute kidney injury patients and their impact on patient outcomes in Indian ICUs (pracRRT Study)  
Trial Acronym  pracRRT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KANWALPREET SODHI 
Designation  DIRECTOR HEAD CRITICAL CARE 
Affiliation  DEEP HOSPITAL 
Address  DEEP HOSPITAL MODEL TOWN LUDHIANA

Ludhiana
PUNJAB
141002
India 
Phone  9465430748  
Fax    
Email  drkanwal2006@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  KANWALPREET SODHI 
Designation  DIRECTOR HEAD CRITICAL CARE 
Affiliation  DEEP HOSPITAL 
Address  DEEP HOSPITAL MODEL TOWN LUDHIANA

Ludhiana
PUNJAB
141002
India 
Phone  9465430748  
Fax    
Email  drkanwal2006@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DEEPA YADAV 
Designation  ISCCM RESEARCH COORDINATOR 
Affiliation  ISCCM Research 
Address  Research coordinator(Office block) INDIAN SOCIETY OF CRITICAL CARE MEDICINE Hind Sevice Ind Premises Coop Society Near Chaitya Bhoomi Dadar Mumbai

Mumbai
MAHARASHTRA
400028
India 
Phone  8655680262  
Fax    
Email  research@isccm.org  
 
Source of Monetary or Material Support  
No financial support 
 
Primary Sponsor  
Name  No sponsor 
Address  Not applicable 
Type of Sponsor  Other [No sponsor] 
 
Details of Secondary Sponsor  
Name  Address 
No sponsor  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR KANWALPREET SODHI  DEEP HOSPITAL  Director & Head Department of Critical Care Medicine Deep Hospital MODEL TOWN LUDHIANA
Ludhiana
PUNJAB 
9465430748

drkanwal2006@yahoo.com 
Dr Sheila Myatra Nainan  Tata Memorial Hospital  Professor, Department of Anaesthesia and Critical Care Medicine Tata Memorial Hospital Mumbai
Mumbai
MAHARASHTRA 
9820156070

sheila150@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 17  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Rishikesh Institutional Ethics Committee  Approved 
Banaras Hindu University Institute of Medical Sciences Institutional Ethics Committee Varanasi  Approved 
Bharti Vidya Peeth Pune Institutional Ethics Comittee  Approved 
Citizens Institutional Ethics Committee  Approved 
Ethics Committee Shanti hospital Shanti Memorial Hospital Pvt Ltd Cuttack  Approved 
Fortis Hospital Ludhiana Institutional Ethics Committee  Approved 
IEC-YAMER  Approved 
Institute Ethics Committee St Stephens Hospital Tis Hazari Delhi  Approved 
Institutional Ethics Comittee Biomedical Research Apollo Hospitals Chennai  Approved 
INSTITUTIONAL ETHICS COMITTEE DEEP HOSPITAL MODEL TOWN LUDHIANA  Approved 
Institutional Ethics Committee (IEC) Dayanand Medical College & Hospital Ludhiana  Approved 
INSTITUTIONAL ETHICS COMMITTEE Biomedical Research Tagore Hospital & Heart Care Centre Pvt Ltd  Approved 
INSTITUTIONAL ETHICS COMMITTEE Yashodha Academy of Medical Education and Research (IEC-YAMER) Secundrabad  Approved 
Kalinga Hospital Ethics Committee   Approved 
Medanta Institutional Ethics comittee  Approved 
shri Mata Vaishno Devi Narayana superspeciality hospital Ethics committee  Approved 
SPS Hospitals Ludhiana Institutional Ethics Comittee  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  90.00 Year(s)
Gender  Both 
Details  1. Patients > 18 years
2. Confirmed ACUTE KIDNEY INJURY (AKI) on any mode of RENAL REPLACEMENT THERAPY (RRT)
 
 
ExclusionCriteria 
Details  1. K/C/O Chronic Kidney Disease (CKD)
2. Patients requiring RRT in ICU for complications arising from their CKD condition
3. AKI patient not requiring RRT
4. Patients who received RRT for AKI during any previous hospitalization
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Intensive Care Unit (ICU mortality)
2. To assess the practices of Renal Replacement Therapy in various ICUs across the country
 
2 months period 
 
Secondary Outcome  
Outcome  TimePoints 
• Hospital Mortality
• Renal recovery
• To assess the association of current RRT practices in critically ill with patient outcomes including survival, renal recovery, length of stay
 
follow up upto 3 months 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   15/04/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Acute kidney injury (AKI) is a common accompaniment in critically ill intensive care unit (ICU) patients, with almost 20% of them needing renal replacement therapy (RRT) at some point of hospitalization. RRT practices beyond the mode of therapy, including the timing of initiation, the hardware used, the type of anticoagulation are known to have varying impacts on the patient outcomes including the recovery of kidney function, the morbidity and mortality. RRT is being widely practiced in India, however, the practices are neither uniform nor standardized. Not much data is available from Indian ICUs on the RRT practices and the outcomes thereof.

A pan-nation survey from Indian ICUs in 2020 assessed the RRT practices and RRT resources available in ICUs of various institutions across the country. The survey across 320 institutions attempted to study the factors influencing the indication, initial RRT modality preference, differences in practices with respect to setup of the treating hospitals and data related to indications of CRRT, time of initiation, and anticoagulation used were collected. Being an online survey, the study had its limitations with the data collected being relatively qualitative in nature, the survey was performed exclusively among critical care physicians while the RRT practices among nephrologists may be different and were not reflected in the survey.

The ISCCM guidelines on AKI and RRT had been available online for over an year, but their acceptance into clinical practice is also not known as of now.

With a substantially high utilization of RRT for AKI management in the ICU population, with paucity of quality data from the Indian ICUs, we plan to conduct a prospective observational study to study the prevalent RRT practices and their impact on patient outcomes across the Indian ICUs including the modality of RRT used, at what stage of AKI RRT was planned, the timing and stage of AKI when RRT initiated, the hardware and anticoagulation used, and the outcomes in terms of renal recovery and mortality modality used, the hardware, the time and stage of AKI when RRT initiated. Eventually, the data can help us evolve policies to standardize RRT practices across the country and improve the RRT utilization in management of AKI patients subsequently.

Objectives:

·       To capture the prevalent RRT practices in Indian ICUs

·       To determine the factors associated with the various RRT practices that can affect the outcomes in patients  with AKI, including mortality and the renal recovery.

·       To objectively look into whether Indian guidelines on RRT have been brought into practice

 
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