Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07004387

Perioperative Use of Amino Acids in Recipients of Orthotopic Liver Transplantation as a Renal Protective Factor

Orthotopic liver transplantation is the definitive treatment for end-stage liver failure, with renal failure being an important complication of this procedure that has implications for long- and short-term prognosis, affecting ICU stay and hospitalization time. Several studies have suggested that intravenous amino acids, particularly L-arginine, may have protective effects on renal function due to increased renal blood flow, which could be explained by enhanced production of nitric oxide among other mechanisms that are still unclear. In this context, we developed the hypothesis that the infusion of an amino acid solution in the perioperative period could reduce the incidence of acute renal failure in this group of patients; for this, we conducted a monocentric, analytical, prospective, interventional pilot study comparing standard treatment (in historically transplanted patients) with a group of patients who were administered amino acids in the perioperative period, considering that this medication is low-cost and has practically minimal side effects.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hepatic Failure Acute Kidney Injury Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hepatic Insufficiency Kidney Diseases Liver Diseases Liver Failure Liver Transplant Male Urogenital Diseases Renal Failure, Acute Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sotero Del Rio

Santiago, Puente ALTO, Chile

Location contact

GUILLERMO A MOLINA

CONTACT

GUILLERMO A MOLINA MANCERO, CRITICAL CARE SPECIALIST

PRINCIPAL_INVESTIGATOR

About this study

The primary objectives will be to measure the occurrence of acute kidney injury according to KDIGO criteria, evaluate the behavior of BUN and creatinine, as well as the initiation and duration of renal replacement therapy if necessary, use of vasopressors, diuresis, liver enzymes and bilirubin, lactate; this will be during the first 10 days postoperatively. Additionally, as a secondary objective, to measure all-cause mortality at 30 days. The study protocol must be approved by the institution's ethics committee. The treatment with amino acids will be carried out using Aminoven 10% from Fresenius Kabi available at the hospital. Fresenius Kabi has not had and will not have any role in the conception, development, data collection, and/or tabulation of data and/or publication of the results of this study. Data collection will be undertaken by specific personnel chosen from among those healthcare providers of liver transplantation, surgery, anesthesiology, and intensive care services.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients assigned to receive a liver transplant will be evaluated for eligibility.
  • Patients over 18 years old scheduled for a liver transplant will be considered eligible if it is expected that they will have an ICU stay of at least 24 hours in the immediate postoperative period, regardless of the cause of liver failure and whether it was stable liver failure or acute on chronic liver failure.
  • They must have a baseline measurement of serum creatinine that does not exceed 30 days prior to surgery or can be taken before the transplant surgery.

Exclusion criteria

  • Patients under 18 years old will be excluded.
  • Patients with a need for chronic hemodialysis, patients with chronic kidney disease with an estimated glomerular filtration rate of less than 30 ml per minute per 1.73 square meters of body surface area calculated by the Cockcroft-Gault equation.
  • Patients with acute renal failure requiring acute intermittent or continuous renal replacement therapy during the hospitalization for surgery.
  • Patients who refuse informed consent to participate in the study.

Treatment and study plan

Amino acid solution

Drug

Adult patients scheduled for orthotopic liver transplant to receive an intravenous infusion of a mixture of amino acids including L arginine, at a dose of 2 g per kg of ideal body weight up to a maximum of 100 g per day, from their admission to the operating room until three days after surgery; the infusion will begin in the operating room prior to the start of the surgery, will be administered through an exclusive lumen of a central venous catheter (CVC) immediately after the CVC is in place; the infusion will continue when the patient is in the intensive care unit (ICU); as soon as the patient begins enteral nutrition, the infusion will be reduced to meet the dose of 2 g per kg of protein intake per day up to a maximum of 100 g daily, until completing 72 H of infusion. The Control Group consists of previously transplanted patients at this institution who did not receive this type of therapy.

Other names: l arginine

Amino Acid infusion

Drug

adult patients scheduled for orthotopic liver transplant to receive an intravenous infusion of a mixture of amino acids including L arginine, at a dose of 2 g per kg of ideal body weight up to a maximum of 100 g per day, from their admission to the operating room until three days after surgery; the infusion will begin in the operating room prior to the start of the surgery, will be administered through an exclusive lumen of a central venous catheter (CVC) immediately after the CVC is in place; the infusion will continue when the patient is in the intensive care unit (ICU); as soon as the patient begins enteral nutrition, the infusion will be reduced to meet the dose of 2 g per kg of protein intake per day up to a maximum of 100 g daily, until completing 72 H of infusion. The Control Group consists of previously transplanted patients at this institution who did not receive this type of therapy.

Other names: l arginina

Primary outcomes

  1. acute kidney failiure

    Time frame: During the first 10 days of the postoperative period

    measure the incidence of renal failure in the postoperative period of liver transplantation

Secondary outcomes

  1. liver function post Liver Transplant

    Time frame: For ten days after the postoperative period

    serial measurement of liver enzymes and bilirubin, lactate.

  2. Need for vasopressors

    Time frame: For ten days postoperatively.

    Doses of noradrenaline, adrenaline, and/or vasopressin

  3. Mortality from all causes.

    Time frame: At 28 days

    Mortality from all causes.

Study contacts

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

GUILLERMO A MOLINA, SPECIALIST IN CRITICAL CARE

CONTACT

[email protected]

988258412

Sponsors and collaborators

Lead sponsor

Hospital Dr Sotero del Rio

Other

Registry information

Acronym: PAATHO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Jun 4, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.