NCT01860716

Impact of Melatonin in the Pretreatment of Organ Donor and the Influence in the Evolution of Liver Transplant.

Impact of Melatonin in the Pretreatment of Organ Donor and the Influence in the Evolution of Liver Transplant: a Prospective, Randomised Double-blind Study.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Aragon Institute of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will be done in the Hospital Clinico Lozano Blesa (Zaragoza, Spain), promoted by the Health Science Aragon Institute and its principal investigator is F. Agustín García Gil (Surgical Service). It will start in April-May 2013 and will finish 12 months later approximately. The study sponsor is I+CS (Aragon Institute of Health Sciences).

Conditions

• Evidence of Liver Transplantation

Interventions

Type	Name	Description
DRUG	Melatonin	Melatonin 2 mg prolonged-release tablet, administration via nasogastric tube.
DRUG	Placebo

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-05-23
• Last updated: 2013-05-23

Locations

1 site across 1 country: Spain