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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2026-09-01

Brief Summary

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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.

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Detailed Description

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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

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Liver Transplant; Complications AKI - Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Amino acid mixture infusion with 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

Group Type EXPERIMENTAL

L-Amino acid mixture

Intervention Type 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

Standard of care

Intervention Type 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.

Standard care

Standard peri liver transplant care as per our institution

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type 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.

Interventions

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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

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No