FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/01/101335 [Registered on: 16/01/2026] Trial Registered Prospectively
Last Modified On: 16/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Nutraceutical
Other (Specify) [Standard of Care]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study on giving amino acids to patients to reduce kidney injury after liver transplant 
Scientific Title of Study   The efficacy of Intravenous amino acids in reducing the occurrence of AKI after Live Donor Liver Transplant: An Open Label Randomized Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ravi Roshan 
Designation  Senior Resident, Dept 
Affiliation  Institute of liver and biliary science  
Address  3rd Floor, phase 2, Department of HPB Surgery and liver transplant, ILBS Hospital, D1, Vasant Kunj

South
DELHI
110070
India 
Phone  8010396811  
Fax    
Email  raviroshan10011994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nilesh S Patil 
Designation  Associate Professor, Dept of HPB Surgery 
Affiliation  ILBS 
Address  3rd Floor, phase 2, Department of HPB Surgery and liver transplant,ILBS Hospital, D1, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9911594576  
Fax    
Email  dr.nils.p@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nilesh S Patil 
Designation  Associate Professor, Dept of HPB Surgery 
Affiliation  ILBS 
Address  3rd Floor, phase 2, Department of HPB Surgery and liver transplant,ILBS Hospital, D1, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9911594576  
Fax    
Email  dr.nils.p@gmail.com  
 
Source of Monetary or Material Support  
ILBS Hospital, D1 Vasant Kunj, New Delhi 110070 
 
Primary Sponsor  
Name  ILBS 
Address  ILBS Hospital, D1 Vasant Kunj, New Delhi 110070 
Type of Sponsor  Research institution and hospital 
 
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 Ravi Roshan  ILBS Hospital   4th Floor, phase 1, liver transplant ICU,ILBS Hospital, ILBS Hospital, D1 Vasasnt Kunj, New Delhi 110070
South West
DELHI 
8010396811

raviroshan10011994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ILBS  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, (3) ICD-10 Condition: K743||Primary biliary cirrhosis, (4) ICD-10 Condition: K717||Toxic liver disease with fibrosisand cirrhosis of liver, (5) ICD-10 Condition: C220||Liver cell carcinoma, (6) ICD-10 Condition: C221||Intrahepatic bile duct carcinoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous Amino Acid with standard of Care  Continuous infusion of L-amino acids mixture in a dose of 2 g per kg dry body weight per day (to a maximum 100 g per day) after induction of anesthesia and insertion of CVP line till 72 hours after treatment initiation in patient undergoing Living donor liver transplant. 
Comparator Agent  Standard of Care   Standard Peri Transplant care in Transplant ICU including initation of immunosuppresents after monitoring daily blood investigation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All Living donor liver transplant recipient (LDLT) Recipient
Signed informed consent
 
 
ExclusionCriteria 
Details  1. Negative consent.
2. Pediatric LDLT.
3. ALF patient undergoing LDLT.
4. Patients on intermittent or continuous renal replacement therapy.
5. Patients with eGFR less then 40 ml per min per 1.73 m2.
6. SLKT and prior Kidney transplant.
7. Patient has a hypersensitivity (known allergy) to one or more of the included amino acids.
8. Patient has a known congenital alteration of amino acid metabolism.

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of early post transplant AKI (within 1st week) in patients undergoing LDLT between L-amino acids infusion and standard treatment groups.  within 1st week 
 
Secondary Outcome  
Outcome  TimePoints 
To Determine the severity of early post Liver transplant AKI  within 1st week 
To determine eGFR at Day 30 and 90 post transplant.  Day 90  
The use and duration of kidney-replacement therapy during the hospital stay
 
1 month 
To determine the factors responsible for occurrence of early post-transplant AKI  within 1st week 
In Hospital Mortality  1 month 
The duration of mechanical ventilation, ICU stay and in hospital stay.   1 month 
Major Morbidity (Clavien-Dindo more than equal to 3) and Early Graft Dysfunction  1 month 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 3 
Date of First Enrollment (India)   28/01/2026 
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="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Acute Kidney Injury (AKI) remains a common and serious complication following live donor liver transplantation (LDLT), with incidence rates ranging upto 60%. AKI increases patient morbidity, hospital stay, need for renal replacement therapy, and mortality. Several risk factors contribute to post-transplant AKI, including intraoperative hemodynamic shifts, ischemia-reperfusion injury, and immunosuppressive nephrotoxicity. Emerging evidence suggests that perioperative administration of intravenous amino acids  reduces the incidence of AKI by Increasing renal perfusion, renal oxygenation, and GFR.


This prospective, open-label, randomized controlled trial aims to evaluate the efficacy of intravenous amino acid infusion in reducing AKI after LDLT. Eligible adult patients undergoing LDLT will be randomized into two groups: one receiving Continuous infusion of a L-amino acids mixture in a dose of 2 g/kg dry body weight/day (to a maximum 100 g/day) after induction of anesthesia and insertion of CVP line till 72 hours after treatment initiation, and the other receiving standard management. The primary outcome is the incidence of AKI as per KDIGO criteria within 7 days of transplant. Secondary outcomes include early graft dysfunction, need for renal replacement therapy, ICU and inhospital stay, and  Major Morbidity. serum NGAL and cystatin C levels will be assessed as early AKI biomarker.

The findings of this study will help establish whether amino acid infusion can be a cost-effective, safe, and easily implementable strategy for AKI prevention in liver transplant patients, thereby improving outcomes.


 
Close