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Melatonin and Cardiac Outcome After Major Surgery

This study has been completed.
Information provided by:
University Hospital, Gentofte, Copenhagen Identifier:
First received: April 18, 2006
Last updated: June 29, 2010
Last verified: November 2006
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
    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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00315926

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

Responsible Party: Dr. Bülent Kücükakin, dept. of surgery, Gentofte Hospital, Copenhagen, Denmark Identifier: NCT00315926     History of Changes
Other Study ID Numbers: 2612-3109
Study First Received: April 18, 2006
Last Updated: June 29, 2010

Keywords provided by University Hospital, Gentofte, Copenhagen:
Cardiac morbidity

Additional relevant MeSH terms:
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants processed this record on August 18, 2017