Not yet recruiting NCT07132697

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

No phase Interventional Liver Transplant; Complications AKI - Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: L-Amino acid mixture, Standard of care.
Who it may be relevant to: Registry conditions: Liver Transplant; Complications, AKI - Acute Kidney Injury. Basic parameters: 18 years — 70 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: India
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Efficacy of Intravenous Amino Acids in Reducing the Occurrence of AKI After Live Donor Liver Transplant: An Open Label Randomized Trial

Overview

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

Interventions

Drug 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
Other Standard of care
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.

Primary outcome measures

To compare the incidence of early post transplant AKI [Time frame: Within 7 days post transplant]

Secondary outcome measures (6)

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

Eligibility criteria

Inclusion criteria

All LDLT Recipient
Age: > 18 years
Signed informed consent

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Prevention

Study locations

India · 1 center

Ilbs Hospital, D1 Vasant Kunj, New Delhi — New Delhi

Identifiers

NCT: NCT07132697 · IEC/2025/119/MA05

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗