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

ConditionsLiver Transplant; ComplicationsAKI - Acute Kidney Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All LDLT Recipient

Age: > 18 years

Signed informed consent

Disqualifiers

Negative consent.

Pediatric LDLT.

ALF patient undergoing LDLT.

Patients on intermittent or continuous renal replacement therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Amino acid mixture infusion with standard of careExperimental treatment 2 interventions
Group B: Standard careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To compare the incidence of early post transplant AKI

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

Time frame
Within 7 days post transplant

Secondary outcomes

1

To Determine the severity of early post Liver transplant AKI

To Determine the severity of early post Liver transplant AKI

Time frame
7 days
2

To determine eGFR at Day 30 and 90.

To determine eGFR at Day 30 and 90.

Time frame
90 days
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

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
4

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

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

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Liver and Biliary Sciences, India

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: