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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Dr Sotero del Rio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Amino acid interventión groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

acute kidney failiure

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

Time frame
During the first 10 days of the postoperative period

Secondary outcomes

1

liver function post Liver Transplant

serial measurement of liver enzymes and bilirubin, lactate.

Time frame
For ten days after the postoperative period
2

Need for vasopressors

Doses of noradrenaline, adrenaline, and/or vasopressin

Time frame
For ten days postoperatively.
3

Mortality from all causes.

Mortality from all causes.

Time frame
At 28 days

Other outcomes

Sponsors and contacts

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