JMIR Publications

ABSTRACT

Background:

Postreperfusion syndrome can appear during liver transplantation as a deep hemodynamic instability and hyperfibrinolysis. Since its first description in 1987, the incidence has remained unchanged despite efforts made. Meanwhile, the antioxidant effect of ascorbic acid has been investigated in the resuscitation of septic shock and burn patients, with contradictory results. In the field of transplantation, its addition to preservation solutions has been investigated to take advantage of this antioxidant effect. Since postreperfusion syndrome could be considered part of the ischemia reperfusion injury in solid organ transplantation, its beneficial effect on the mitigation of ischemia reperfusion injury and the appearance of postreperfusion syndrome should be investigated.

Objective:

The aim of this randomized clinical trial is to assess the benefits of ascorbic acid compared to saline regarding postreperfusion syndrome development during adult liver transplantation.

Methods:

This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Hospital Universitario Ramón y Cajal in Spain. A total of 70 subjects over the age of 18 years and undergoing liver transplantation will be assigned by simple randomization to receive either ascorbic acid or saline. The primary outcome will be the differences between groups in the incidence of postreperfusion syndrome. The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions.

Results:

The inclusion process started in 2020. Data cleaning and analyses are expected to take place in the last quarter of 2023 and the results are expected in the beginning of 2024.

Conclusions:

This study is particularly relevant as it will be the first to analyze the clinical effect of ascorbic acid during liver transplantation. We believe that our study addresses an important gap in the knowledge of the possible benefits of ascorbic acid in the field of liver transplantation, and concretely the benefit over postreperfusion syndrome. Clinical Trial: European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) (2020-000123-39); ClinicalTrials.gov (NCT05754242).