Impact of Melatonin in the Pretreatment of Organ Donor and the Influence in the Evolution of Liver Transplant.
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Impact of melatonin on organ donor pretreatment and liver transplant recipient: prospective,
randomized, double-blind trial.
OBJECTIVES. To establish the efficacy of the melatonin administered to encephalic death
donors (EDD) in liver transplantation. The aim is to improve the functional quality of the
retrieved organs, attenuate lesions and ischemia-reperfusion mediators, and provide grafts
with greater resistance to post-transplant aggression.
METHODOLOGY. Prospective, randomized, double-blind, pilot trial to evaluate preconditioning
with melatonin versus placebo in EDDs. Two groups, melatonin and control-placebo, n=30 per
group. Administration to donor via NG tube of 30mg of melatonin or placebo (lactose) upon
inclusion in the trial, 60 minutes prior to commencement of surgery and following laparotomy
during extraction. Evaluation of response to treatment: A) Conventional clinical,
hemodynamic, analytical and histopathological parameters in donor and recipient. B) Plasma
determinations for: oxidative/nitrosative stress; acute phase proteins; cellular and humoral
immunity; NT-proBNP and cystatin C; endocrine profile; melatonin levels. C) Determinations in
liver tissue: quantification of malonyldialdehyde-4hydroxyalkenals and protein carbonyl
content; cellular and mitochondrial membrane fluidity; markers of tissue-vascular damage and
proliferation: transforming growth factor-beta (TGF-β); hypoxia-inducible factor (HIF) and
vascular endothelial growth factor (VEGF). Data will be analyzed following a prospectively
define plan and by intention-to-treat analysis.