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NCT Number: NCT07132697

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

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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Key information

Conditions

Liver Transplant; Complications AKI - Acute Kidney Injury Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ilbs Hospital, D1 Vasant Kunj, New Delhi

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

Location contact

Ravi Roshan, MBBS, MS

CONTACT

[email protected]

8010396811

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. To compare the incidence of early post transplant AKI

    Time frame: 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 outcomes

  1. To Determine the severity of early post Liver transplant AKI

    Time frame: 7 days

    To Determine the severity of early post Liver transplant AKI

  2. To determine eGFR at Day 30 and 90.

    Time frame: 90 days

    To determine eGFR at Day 30 and 90.

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

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

    Time frame: 1 month

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

  5. In Hospital Mortality

    Time frame: 1 month

    In Hospital Mortality

  6. Major Morbidity (Clavien-Dindo ≥3) and Early Graft Dysfunction.

    Time frame: 1 month

    Major Morbidity (Clavien-Dindo ≥3) and Early Graft Dysfunction.

Study contacts

Contact information is provided by the study sponsor or research team.

Nilesh Patil

CONTACT

[email protected]

+91 99115 94576

Ravi Roshan

CONTACT

[email protected]

+91 8010396811

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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