Impact of Melatonin in the Pretreatment of Organ Donor and the Influence in the Evolution of Liver Transplant.
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|ClinicalTrials.gov Identifier: NCT01860716|
Recruitment Status : Unknown
Verified May 2013 by Aragon Institute of Health Sciences.
Recruitment status was: Not yet recruiting
First Posted : May 23, 2013
Last Update Posted : May 23, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Evidence of Liver Transplantation||Drug: Melatonin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Impact of Melatonin in the Pretreatment of Organ Donor and the Influence in the Evolution of Liver Transplant: a Prospective, Randomised Double-blind Study.|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Placebo Comparator: Solution for infusion
Solution for infusion administrated via nasogastric tube
30 mg melatonin administrated via nasogastric tube in the Intensive Care Unit when included in the study and 30 mg melatonin 60 minutes before transfer to the operating room.
Melatonin 2 mg prolonged-release tablet, administration via nasogastric tube.
Other Name: Circadin (Neurim Pharmaceuticals)
- AST levels [ Time Frame: Between days 1 and 10 postoperatively. ]Aspartate transaminase (AST) levels will be measured.
- ALT [ Time Frame: Between days 1 and 10 postoperatively ]Alanine transaminase (ALT) levels will be measured.
- Bilirubin levels [ Time Frame: Between days 1 and 10 postoperatively ]Bilirubin levels will be measured.
- Prothrombin levels [ Time Frame: Between days 1 and 10 postoperatively ]Prothrombin levels will be measured.
- Post-reperfusion syndrome [ Time Frame: Transplant day ]Post-reperfusion syndrome
- No primary function and primary graft dysfunction [ Time Frame: Transplant day ]No primary function and primary graft dysfunction
- Survival of the graft [ Time Frame: From day 0 to 3 months ]Survival of the graft
- Patient survival [ Time Frame: Day 0 to 3 months ]Patient survival
- Donor and recipient serological parameters [ Time Frame: Between days 1 and 10 postoperatively ]Donor and recipient serological parameters
- Morphological and functional quality of the liver graft evaluated by histological parameters of ischemia-reperfusion and tissue biochemical markers [ Time Frame: Day 0 and day 1 ]Morphological and functional quality of the liver graft evaluated by histological parameters of ischemia-reperfusion and tissue biochemical markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860716
|Hospital Clínico Universitario Lozano Blesa||Not yet recruiting|
|Zaragoza, Spain, 50009|
|Contact: Francisco A. García-Gil, Physician 0034976765700 firstname.lastname@example.org|
|Principal Investigator: Francisco A. García-Gil, Physician|
|Principal Investigator:||Francisco A. García-Gil, Physician||Hospital Clínico Universitario Lozano Blesa|