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

Not Applicable

Not yet recruiting

• Conditions: Liver Transplant; Complications; AKI - Acute Kidney Injury
• Interventions: Drug: L-Amino acid mixture; Other: Standard of care

• Registration Number: NCT07132697
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Study Start: 2025-08-25
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amino acid mixture infusion with standard of care	L-Amino acid mixture	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	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
Standard care	Standard of care	Standard peri liver transplant care as per our institution

Primary Outcome Measures

Name	Time	Method
To compare the incidence of early post transplant AKI	Within 7 days post transplant	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

Secondary Outcome Measures

Name	Time	Method
To Determine the severity of early post Liver transplant AKI	7 days	To Determine the severity of early post Liver transplant AKI
To determine eGFR at Day 30 and 90.	90 days	To determine eGFR at Day 30 and 90.
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 use and duration of kidney-replacement therapy during the hospital stay The use and duration of kidney-replacement therapy during the hospital stay
The duration of mechanical ventilation, ICU stay and in hospital stay.	1 month	The duration of mechanical ventilation, ICU stay and in hospital stay.
In Hospital Mortality	1 month	In Hospital Mortality
Major Morbidity (Clavien-Dindo ≥3) and Early Graft Dysfunction.	1 month	Major Morbidity (Clavien-Dindo ≥3) and Early Graft Dysfunction.

Trial Locations

Locations (1)

Ilbs Hospital, D1 Vasant Kunj, New Delhi; 🇮🇳 New Delhi, Delhi, India