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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

April 18, 2006
June 29, 2010
January 2007
July 2008   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00315926 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00315926
2612-3109
Yes
Dr. Bülent Kücükakin, dept. of surgery, Gentofte Hospital, Copenhagen, Denmark
University Hospital, Gentofte, Copenhagen
Not Provided
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