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

NCT07004387 | Not Yet Recruiting

• 1 other identifier: AMUCI-25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatic Failure; Liver Transplant; Renal Failure, Acute

Keywords

liver transplant; renal failiure; amino acids; surguery; ICU

Outcome Measures

Primary Outcomes (1)

• acute kidney failiure

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

  During the first 10 days of the postoperative period

Secondary Outcomes (3)

• liver function post Liver Transplant

  For ten days after the postoperative period

• Need for vasopressors

  For ten days postoperatively.

• Mortality from all causes.

  At 28 days

Study Arms (1)

Amino acid interventión group

EXPERIMENTAL

Patients over 18 years old scheduled to undergo liver transplantation who are expected to 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 will receive an intravenous infusion of a mixture of amino acids that includes 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 the surgery.

Drug: Amino acid solution; Drug: Amino Acid infusion

Interventions

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.

Also known as: l arginine

Amino acid interventión group

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.

Also known as: l arginina

Amino acid interventión group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Dr Sotero del Rio: lead

Study Sites (1)

Hospital Sotero Del Rio

Santiago, Puente ALTO, Chile

Location

Related Publications (4)

• Landoni G, Monaco F, Ti LK, Baiardo Redaelli M, Bradic N, Comis M, Kotani Y, Brambillasca C, Garofalo E, Scandroglio AM, Viscido C, Paternoster G, Franco A, Porta S, Ferrod F, Calabro MG, Pisano A, Vendramin I, Barucco G, Federici F, Severi L, Belletti A, Cortegiani A, Bruni A, Galbiati C, Covino A, Baryshnikova E, Giardina G, Venditto M, Kroeller D, Nakhnoukh C, Mantovani L, Silvetti S, Licheri M, Guarracino F, Lobreglio R, Di Prima AL, Fresilli S, Labanca R, Mucchetti M, Lembo R, Losiggio R, Bove T, Ranucci M, Fominskiy E, Longhini F, Zangrillo A, Bellomo R; PROTECTION Study Group. A Randomized Trial of Intravenous Amino Acids for Kidney Protection. N Engl J Med. 2024 Aug 22;391(8):687-698. doi: 10.1056/NEJMoa2403769. Epub 2024 Jun 12.

  PMID: 38865168 BACKGROUND

• Pu H, Doig GS, Heighes PT, Allingstrup MJ, Wang A, Brereton J, Pollock C, Chesher D, Bellomo R. Intravenous amino acid therapy for kidney protection in cardiac surgery patients: A pilot randomized controlled trial. J Thorac Cardiovasc Surg. 2019 Jun;157(6):2356-2366. doi: 10.1016/j.jtcvs.2018.11.097. Epub 2018 Dec 15.

  PMID: 30685166 BACKGROUND

• Pruna A, Losiggio R, Landoni G, Kotani Y, Redaelli MB, Veneziano M, Lee TC, Zangrillo A, Gaudino MFL, Bellomo R; for Protection Study group. Amino Acid Infusion for Perioperative Functional Renal Protection: A Meta-analysis. J Cardiothorac Vasc Anesth. 2024 Dec;38(12):3076-3085. doi: 10.1053/j.jvca.2024.08.033. Epub 2024 Aug 22.

  PMID: 39384419 BACKGROUND

• Hoffmann K, Buchler MW, Schemmer P. Supplementation of amino acids to prevent reperfusion injury after liver surgery and transplantation--where do we stand today? Clin Nutr. 2011 Apr;30(2):143-7. doi: 10.1016/j.clnu.2010.09.006. Epub 2010 Oct 20.

  PMID: 20965621 BACKGROUND

MeSH Terms

Conditions

Liver Failure; Acute Kidney Injury

Interventions

amino-acid, glucose, and electrolyte solution; Arginine

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Central Study Contacts

GUILLERMO A MOLINA, SPECIALIST IN CRITICAL CARE

CONTACT

988258412; guillermo.molina@sotero.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SPECIALIST IN INTENSIVE CARE MEDICINE

Model Details: A pilot, prospective, non-randomized, analytical study with intervention, in which adult patients scheduled for orthotopic liver transplantation will be assigned 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 the surgery. The infusion will begin in the operating room, prior to the start of the surgery, and will be performed 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 2 g per kg of protein intake per day, up to a maximum of 100 g per day, until completing 72 hours of infusion. The control group consists of cases of previously transplanted patients.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): May 27, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

CL (1)