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

Institute of Liver and Biliary Sciences, India

Status: Not yet enrolling

Conditions: Liver Transplant; Complications; AKI - Acute Kidney Injury

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07132697

IEC/2025/119/MA05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. All LDLT Recipient
2. Age: > 18 years
3. Signed informed consent

Exclusion Criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Amino acid mixture infusion with standard of care

Experimental group

Description:

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

Treatment:

Other: Standard of care

Drug: L-Amino acid mixture

Standard care

Active Comparator group

Description:

Standard peri liver transplant care as per our institution

Treatment:

Other: Standard of care