| CTRI Number |
CTRI/2025/07/090026 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
SURVEY STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Perioperative CRRT (Continous Renal Replacement Therapy) practices in management of acute liver failure (ALF) patients undergoing Liver transplantation - A survey based study |
|
Scientific Title of Study
|
Perioperative CRRT (Continous Renal Replacement Therapy) practices in management of acute liver failure (ALF) patients undergoing Liver transplantation - A survey based study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonam Satija |
| Designation |
Assistant Professor Anaesthesia |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
C-21, First floor, Lajpat nagar 1 C-21, First floor, Lajpat nagar 1 New Delhi DELHI 110024 India |
| Phone |
8130657296 |
| Fax |
|
| Email |
sonamravigupta1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sonam Satija |
| Designation |
Assistant Professor Anaesthesia |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
C-21, First floor, Lajpat nagar 1 C-21, First floor, Lajpat nagar 1 New Delhi DELHI 110024 India |
| Phone |
8130657296 |
| Fax |
|
| Email |
sonamravigupta1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
SONAM SATIJA |
| Designation |
ASSISSTANT PROFESSOR ANAESTHESIA |
| Affiliation |
Institute of liver and biliary sciences |
| Address |
Department of Anaesthesia, Institute of Liver and Biliary sciences, Vasant Kunj.
4th floor, phase 1, ILBS Department of Anaesthesia, Institute of Liver and Biliary sciences, Vasant Kunj.
4th floor, phase 1, ILBS South DELHI 110070 India |
| Phone |
8130657296 |
| Fax |
|
| Email |
sonamravigupta1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences |
|
|
Primary Sponsor
|
| Name |
ILBS |
| Address |
D-1, VASANT KUNJ, 110070 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonam Satija |
Institute of liver and biliary sciences, vasant kunj |
Department of anaesthesia, Institute of liver and biliary sciences,VASANT KUNJ, 110070
4TH FLOOR, PHASE-1 South DELHI |
8130657296
sonamravigupta1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee, ilbs |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PRACTICES IN ALF |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Transplant centers performing liver transplants
2 Clinicians involved in perioperative management of ALF patients
3 Willingness to participate in the survey
|
|
| ExclusionCriteria |
| Details |
1 Incomplete or duplicate responses
2 Centers that donot manage ALF patients or donot use CRRT
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comprehensive overview of current perioperative CRRT practices
Identification of common indications and clinical rationale
Documentation of practice variability
Insight into role of CRRT in neuroprotection
Understanding practical challenges |
After submission of responses, outcomes will be analysed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
20/07/2025 |
| 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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
ALF is a medical emergency associated with high morbidity and mortality, often necessitating urgent liver transplantation. These patients frequently develop complications such as AKI, metabolic acidosis, and cerebral edema. CRRT is used as a supportive measure in this setting to manage fluid overload, correct electrolyte disturbances, and reduce serum ammonia levels, particularly in hemodynamically unstable patients. Despite widespread use, there is significant variation in the practices of CRRT in perioperative period in ALF patients undergoing liver transplantation. Currently, no standardized national or international guidelines exist to direct clinicians on the appropriate indications, timing, dose, and modality of CRRT during liver transplant surgery. This proposed survey-based study aims to collect data from liver transplant centers to understand how CRRT is utilized during perioperative period in ALF patients undergoing transplantation. It will focus on common indications, institutional protocols, timing of initiation in preoperative, intraoperative period and timing of discontinuation in postoperative period, dose and type of anticoagulant used in CRRT. By identifying the range of clinical practices, challenges, and perceived outcomes, the study seeks to highlight current trends and areas of variability in patient care. The results of this study may help build a foundation for evidence-informed clinical protocols, contribute to knowledge sharing across centres, and encourage the development of consensus guidelines. Importantly, this study is non-interventional in nature-it involves surveying clinicians and doesnot include any direct patient participation or alteration in patient care. |