Melatonin and Cardiac Outcome After Major Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315926
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : June 30, 2010
Information provided by:
University Hospital, Gentofte, Copenhagen

April 18, 2006
April 19, 2006
June 30, 2010
January 2007
July 2008   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT00315926 on Archive Site
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
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Melatonin and Cardiac Outcome After Major Surgery
Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair
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.
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.
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Aortic Aneurysm
  • Drug: Melatonin
    Melatonin 50 mg during surgery and 10 mg every night for 3 nights
  • Drug: Placebo
    a mixture of ethanol and physiological saline
  • Experimental: Melatonin
    Intervention: Drug: Melatonin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2008
July 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Dr. Bülent Kücükakin, dept. of surgery, Gentofte Hospital, Copenhagen, Denmark
University Hospital, Gentofte, Copenhagen
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Principal Investigator: Bülent Kücükakin Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
University Hospital, Gentofte, Copenhagen
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP