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CTRI Number  CTRI/2025/01/078931 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective observational study 
Study Design  Single Arm Study 
Public Title of Study   Restricted fluid therapy in living donor liver transplant  
Scientific Title of Study   Intraoperative Fluid Therapy-Finding A Balance: A Single Centre Experience With Restrictive Fluid Therapy In Adult Living Donor Liver Transplant 
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 Amit Singhal 
Designation  Director 
Affiliation  BLK Max Superspeciality Hospital 
Address  Department of HPB and liver transplant Anesthesia and ciritcal care, BLK Max Superspeciality Hospital, Pusa Road

New Delhi
DELHI
110005
India 
Phone  9891873774  
Fax    
Email  drsinghalamit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Singhal 
Designation  Director 
Affiliation  BLK Max Superspeciality Hospital 
Address  Department of HPB and liver transplant Anesthesia and ciritcal care, BLK Max Superspeciality Hospital, Pusa Road

New Delhi
DELHI
110005
India 
Phone  9891873774  
Fax    
Email  drsinghalamit@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Amit Singhal 
Designation  Director 
Affiliation  BLK Max Superspeciality Hospital 
Address  Department of HPB and liver transplant Anesthesia and ciritcal care, BLK Max Superspeciality Hospital, Pusa Road

New Delhi
DELHI
110005
India 
Phone  9891873774  
Fax    
Email  drsinghalamit@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Amit Singhal 
Address  HPB and Liver transplant Anesthesia and critical care, BLK Max Superspeciality Hospital, New Delhi 110005  
Type of Sponsor  Other [Non funded study] 
 
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 AMIT SINGHAL  BLK Max Superspeciality Hospital   Department of HPB and Liver Transplant Anaesthesia and critical care Second floor, Organ Transplant ICU
New Delhi
DELHI 		 09891873774

drsinghalamit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE DEPARTMENT OF ACADEMIC AFFAIRS RESEARCH & CONTINUING EDUCATION  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, (2) ICD-10 Condition: K703||Alcoholic cirrhosis of liver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  All patients over 18years of age undergoing adult living donor liver transplant from December 2022 to November 2023 will be enrolled in the study 
 
ExclusionCriteria 
Details  - Patients less than 18years of age.
- Patients with H/O recent (less than one week) Hepatorenal syndrome/Acute Kidney Injury
- Patients with known H/O chronic kidney disease
- Patients with Hepatopulmonary syndrome/Portopulmonary Hypertension
- Combined procedure with liver transplant.
- H/O hepatic encephalopathy (Grade 2 or more at the time of transplant)
- Patients with acute liver failure.
INTRAOPERATIVE-
- Patients requiring intraoperative continuous renal replacement therapy
- Patients with incomplete data
POSTOPERATIVE
- Patient requiring mechanical ventilation for graft dysfunction or neurological complications.
- Patient requiring mechanical ventilation for renal replacement therapy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Evaluate our rate of early extubation (on-table extubation, extubated within 4hours postoperatively) after living donor liver transplant, mean duration of mechanical ventilation, pulmonary complications such as pulmonary edema , pleural effusion requiring drainage within 72 hours postoperatively.
•Incidence of Acute kidney injury within 72 hours postoperatively. Need for renal replacement therapy. 		 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative need for packed red blood cells, vasopressor requirement (noradrenaline-mcg/kg/min and total vasopressin units) and rate of vascular complications (hepatic artery thrombosis)  Intraoperative period 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/01/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 05/02/2025 
Estimated Duration of Trial   Years="0"
Months="0"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

We practice weight based restrictive fluid strategy with maintenance therapy at 4ml/kg/h (2ml/kg/h crystalloids + 2ml/kg/h 4%albumin solution) and fluid boluses guided by goal directed parameters.We will retrospectively analyze our data of patients undergoing adult living donor liver transplant in one year period and determine the average fluid requirement and its effect on pulmonary outcomes and incidence of postoperative acute kidney injury. Secondary outcomes will be intraoperative blood and vasopressor requirement(noradrenaline) and vascular complication rate.We hypothesise that our strategy of continuous maintenance therapy with intermittent fluid boluses improves pulmonary outcomes with no increased risk of acute kidney injury. The statistical analysis will be done with the Graph Pad Prism.

 
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