NCT07004387

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Hospital Dr Sotero del Rio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hepatic Failure
• Liver Transplant
• Renal Failure, Acute

Interventions

Type	Name	Description
DRUG	Amino acid solution	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.
DRUG	Amino Acid infusion	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.

Timeline

• Start date: 2025-05-27
• Primary completion: 2026-05-27
• Completion: 2026-09-30
• First posted: 2025-06-04
• Last updated: 2025-06-04

Locations

1 site across 1 country: Chile