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Melatonin and Cardiac Outcome After Major Surgery

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00315926
First received: April 18, 2006
Last updated: June 29, 2010
Last verified: November 2006
  Purpose

The purpose of this study is to assess whether treatment with melatonin can reduce cell damage and inflammatory stress response and thereby occurrence of myocardial injury after abdominal aortic surgery.


Condition Intervention Phase
Aortic Aneurysm
Drug: Melatonin
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Cardiac morbidity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    artrial fibrillation, unstable angina, myocardial infarction, ECG changes (T-wave inversion for more than 24 hours, new ST-segment depression for more than 24 hours, acute ST-segment elevation with appearance of q-waves or loss of R-waves, left bundle branch block), or a characteristic pattern of rising and falling values of troponin-I, or pulmonary oedema. Mortality was defined as any cause of death in the 30 days after surgery.


Secondary Outcome Measures:
  • Oxidative and inflammatory stress response [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Blood samples for analysis of malondialdehyde (MDA), ascorbic acid (AA), dehydroascorbic acid (DHA) and C-reactive protein (CRP) assessed before and after operation


Enrollment: 52
Study Start Date: January 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melatonin Drug: Melatonin
Melatonin 50 mg during surgery and 10 mg every night for 3 nights
Placebo Comparator: Placebo Drug: Placebo
a mixture of ethanol and physiological saline

Detailed Description:

Abdominal aortic surgery is associated with a significant increase of oxidative and inflammatory stress response. Aortic surgery is also associated with elevated troponin which is a sensitive and specific marker for myocardial injury. The severity of oxidative stress is correlated with elevated troponin. Melatonin, which is a hormone produced in brain, seems to modify cell damage and inflammation. On the other hand we know, that melatonin production first night after surgery is disturbed. The purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation, and thereby occurrence of myocardial injury associated with abdominal aortic surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication for elective abdominal aortic aneurism surgery or periphery atheroscleroses with indicated protheses operation
  • Patients between 18 and 80 years old

Exclusion Criteria:

  • Patients with ASA class > 3
  • Anticoagulation therapy (marevan and marcoumar)
  • Preoperative therapy with opioid, anxiolytic and hypnotic medication
  • Renal insufficient (preoperative creatinin > 200 mmol/l)
  • Well-known liver insufficient
  • Alcohol consumption (more than 5 drinks)
  • Compliance (language difficulty, mental problems etc.)
  • Pregnancy and breast-feeding
  • Lack of written consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315926

Locations
Denmark
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
Hellerup, Denmark
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Bülent Kücükakin Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
  More Information

No publications provided

Responsible Party: Dr. Bülent Kücükakin, dept. of surgery, Gentofte Hospital, Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT00315926     History of Changes
Other Study ID Numbers: 2612-3109
Study First Received: April 18, 2006
Last Updated: June 29, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University Hospital, Gentofte, Copenhagen:
Cardiac morbidity
Melatonin
Surgery
Postoperative

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases
Melatonin
Antioxidants
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014