| 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 |
|
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Primary Sponsor
|
| Name |
ILBS |
| Address |
ILBS Hospital, D1 Vasant Kunj, New Delhi 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 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
|
|
|
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.
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
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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.
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