The Efficacy of Intravenous Amino Acids in Reducing the Occurrence of AKI After Live Donor Liver Transplant

NCT07132697 | Not Yet Recruiting

• 1 other identifier: IEC/2025/119/MA05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Transplant; Complications; AKI - Acute Kidney Injury

Keywords

Liver Transplantation, Acute Kidney Injury, Amino Acids, KDIGO, NGAL, Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• To compare the incidence of early post transplant AKI

  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 7 days post transplant

Secondary Outcomes (6)

• To Determine the severity of early post Liver transplant AKI

  7 days

• To determine eGFR at Day 30 and 90.

  90 days

• The use and duration of kidney-replacement therapy during the hospital stay The use and duration of kidney-replacement therapy during the hospital stay

  1 month

• The duration of mechanical ventilation, ICU stay and in hospital stay.

  1 month

• In Hospital Mortality

  1 month

Study Arms (2)

Amino acid mixture infusion with standard of care

EXPERIMENTAL

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

Drug: L-Amino acid mixture; Other: Standard of care

Standard care

ACTIVE COMPARATOR

Standard peri liver transplant care as per our institution

Other: Standard of care

Interventions

L-Amino acid mixture DRUG

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

Amino acid mixture infusion with standard of care

Standard of care OTHER

Standard peri tranplant care as per out institution including intra operative and post operative care. Its includes starting of immunosuppression after serial blood investigation monitoring.

Amino acid mixture infusion with standard of care; Standard care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All LDLT Recipient
• Age: \> 18 years
• Signed informed consent

You may not qualify if:

• Negative consent.
• Pediatric LDLT.
• ALF patient undergoing LDLT.
• Patients on intermittent or continuous renal replacement therapy.
• Patients with eGFR less then 40 ml per min per 1.73 m2.
• SLKT and prior Kidney transplant.
• Patient has a hypersensitivity (known allergy) to one or more of the included amino acids.
• Patient has a known congenital alteration of amino acid metabolism.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Ilbs Hospital, D1 Vasant Kunj, New Delhi

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Ravi Roshan

CONTACT

+91 8010396811; raviroshan10011994@gmail.com

Nilesh Patil

CONTACT

+91 99115 94576; dr.nils.p@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 20, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Locations

IN (1)