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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
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Aragon Institute of Health Sciences

Brief 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.


Condition or disease Intervention/treatment Phase
Evidence of Liver Transplantation Drug: Melatonin Drug: Placebo Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Placebo Comparator: Solution for infusion
Solution for infusion administrated via nasogastric tube
Drug: Placebo
Experimental: Melatonin
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.
Drug: Melatonin
Melatonin 2 mg prolonged-release tablet, administration via nasogastric tube.
Other Name: Circadin (Neurim Pharmaceuticals)




Primary Outcome Measures :
  1. AST levels [ Time Frame: Between days 1 and 10 postoperatively. ]
    Aspartate transaminase (AST) levels will be measured.

  2. ALT [ Time Frame: Between days 1 and 10 postoperatively ]
    Alanine transaminase (ALT) levels will be measured.

  3. Bilirubin levels [ Time Frame: Between days 1 and 10 postoperatively ]
    Bilirubin levels will be measured.

  4. Prothrombin levels [ Time Frame: Between days 1 and 10 postoperatively ]
    Prothrombin levels will be measured.


Secondary Outcome Measures :
  1. Post-reperfusion syndrome [ Time Frame: Transplant day ]
    Post-reperfusion syndrome

  2. No primary function and primary graft dysfunction [ Time Frame: Transplant day ]
    No primary function and primary graft dysfunction

  3. Survival of the graft [ Time Frame: From day 0 to 3 months ]
    Survival of the graft

  4. Patient survival [ Time Frame: Day 0 to 3 months ]
    Patient survival

  5. Donor and recipient serological parameters [ Time Frame: Between days 1 and 10 postoperatively ]
    Donor and recipient serological parameters

  6. 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



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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A) Donors

  1. Encephalic-death (ED) organ donor who is situated in the ICUs of accredited hospitals in Zaragoza and meets each and every one of the following criteria.
  2. Being 16 years old or older.
  3. Informed consent for the donation signed by the immediate family.
  4. Informed consent for inclusion of the donor in the study .
  5. Receive intensive treatment and standard maintenance of the donor in ED, in accordance with universally accepted protocols of the Organizacion Nacional de Trasplantes (ONT), of the Aragon Autonomous Transplant Coordination, and of the ICUs and the participating hospitals in the study.

B) Liver transplant recipients

  1. Being 18 years old or older and being less than 68 years of age.
  2. Informed consent for the procedure of LT signed.
  3. Informed consent for patient inclusion in the study, signed the same day that consent to the LT.

Exclusion Criteria:

A) Donors

A potential encephalic-death organ donor will not be included in the study if either of the following criteria:

  1. Absence of either signed informed consent: for organ donation or for inclusion in the study.
  2. No standard concomitant treatment and management of donor in ED.

B) Liver transplant recipients

  1. Absence of either signed informed consent: for liver transplantation or for inclusion in the study.
  2. Split, domino or multiorgan transplantation.
  3. Grafts removed by other surgical teams.
  4. Pregnant women or fertile not using contraceptive measures highly effective.

Information from the National Library of Medicine

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


Locations
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Spain
Hospital Clínico Universitario Lozano Blesa Not yet recruiting
Zaragoza, Spain, 50009
Contact: Francisco A. García-Gil, Physician    0034976765700    agarciagil@telefonica.net   
Principal Investigator: Francisco A. García-Gil, Physician         
Sponsors and Collaborators
Aragon Institute of Health Sciences
Fondo de Investigacion Sanitaria
Investigators
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Principal Investigator: Francisco A. García-Gil, Physician Hospital Clínico Universitario Lozano Blesa

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Responsible Party: Aragon Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT01860716     History of Changes
Other Study ID Numbers: PI10/02877
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013

Keywords provided by Aragon Institute of Health Sciences:
Melatonin, liver transplant, oxidative stress

Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants