| CTRI Number |
CTRI/2024/07/071234 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Albumin therapy is common and safe. We asses the efficacy of this therapy.] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exploring the Role of Albumin Therapy in Affecting Post-Surgical Abdominal Drainage in ICU Patients After Liver Transplant |
|
Scientific Title of Study
|
Efficacy of albumin infusion for hypoalbuminemia in post operative period in living donor liver transplantation – An open label randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhash Gupta |
| Designation |
Chairman |
| Affiliation |
Max Super Speciality Hospital, Saket, New Delhi |
| Address |
Chairman Room, Liver Transplant Office, Centre for Liver and Biliary Sciences, 5th Floor, West Block, Max Super Speciality Hospital, 1, Press enclave Road, Saket, New Delhi, India, Pin 110017
South
DELHI
110017
India |
| Phone |
8527166415 |
| Fax |
|
| Email |
livertransplant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vipul Gautam |
| Designation |
Consultant |
| Affiliation |
Max centre for liver and biliary sciences |
| Address |
Pediatric Hepatology Room, Liver Transplant Office, Centre for Liver and Biliary Sciences, 5th Floor, West Block, Max Super Speciality Hospital, 1, Press enclave Road, Saket, New Delhi, India
South
DELHI
110017
India |
| Phone |
9990833154 |
| Fax |
|
| Email |
iam.vipulgautam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vipul Gautam |
| Designation |
Consultant |
| Affiliation |
Max centre for liver and biliary sciences |
| Address |
Pediatric Hepatology Room, Liver Transplant Office, Centre for Liver and Biliary Sciences, 5th Floor, West Block, Max Super Speciality Hospital, 1, Press enclave Road, Saket, New Delhi, India
South
DELHI
110017
India |
| Phone |
9990833154 |
| Fax |
|
| Email |
iam.vipulgautam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital, 1, Press enclave Road, Saket, New Delhi, Delhi, India, Pin 110017 |
|
|
Primary Sponsor
|
| Name |
Dr Subhash Gupta |
| Address |
Max Super Speciality Hospital, 1, Press enclave Road, Saket, New Delhi, Delhi, India, Pin 110017 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Vipul Gautam |
Max Super speciality hospital |
Liver Transplant ICU, 4th Floor, Centre for Liver and Biliary Sciences, West Block, 1, Press Enclave Road, Saket, New Delhi, Pin 110017
South
DELHI |
9990833154
iam.vipulgautam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K729||Hepatic failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Human albumin intravenous infusion |
Dose: 20gram (20% Albumin);
Frequency: Once/Twice a day;
Route of Administration: Intravenous Slow Infusion;
Total Duration: For 5 days after the liver transplant surgery |
| Comparator Agent |
Placebo infusion (Normal Saline) |
Dose: 100-200ml/day; Route of Administration: Intravenous Slow Infusion; Total Duration: For 5 days after the liver transplant surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Immediate post living donor liver transplant recipients (Aged greater than 18 years) admitted to the liver transplant intensive care unit |
|
| ExclusionCriteria |
| Details |
1)Pregnancy, 2)Age less than 18 years, 3)Re-transplantation, 4)Deceased donor LT, 5)Greater than 3 organ failure (ACLF grade 3), 6)Pre LT rapid filling ascites or Grade 3 ascites, 7)Primary graft failure, 8)Post LT vascular or biliary complication, 9)Negative consent, 10)Post LT correction of hypoalbuminemia (Sepsis, Hemodynamic instability, acute kidney injury), 11)Graft weight less than 600 grams, 12)Combined liver-kidney transplant
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome is to determine if correcting hypoalbuminemia with albumin infusion in post LT period, helps in decreasing the surgical drain output by 20% on post operative day 5 |
Post Transplant Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of serious adverse events till discharge |
Discharge date |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Analyzing the final data. Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [iam.vipulgautam@gmail.com].
- For how long will this data be available start date provided 01-03-2026 and end date provided 28-02-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Albumin’s role post-liver transplant is debated, with its use aimed at volume replacement and hemodynamic stability. Post-transplant hypoalbuminemia results from multiple factors like capillary leakage due to surgery-induced inflammation. Studies indicate increased albumin synthesis but decreased plasma levels, suggesting redistribution or altered degradation in the post-transplant period. Albumin infusion risks overhydration and volume overload. Previous studies have concluded that critically ill post-transplant patients gain no hemodynamic benefit from albumin over other fluids. Clinically, in our experience (high volume living donor liver transplant center) albumin hasn’t improved fluid management or inotropic support, leading instead to fluid overload, increased drain output, potential tacrolimus toxicity, and higher treatment costs. We planned this trial to assess the efficacy of albumin and rationalize the use of albumin therapy in the postoperative period of liver transplantation. |