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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, |
|
Intervention / Comparator Agent
|
|
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 |