Melatonin and Cardiac Outcome After Major Surgery
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.
|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|
- 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.
- 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
|Study Start Date:||January 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Melatonin 50 mg during surgery and 10 mg every night for 3 nights
|Placebo Comparator: Placebo||
a mixture of ethanol and physiological saline
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315926
|Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte|
|Principal Investigator:||Bülent Kücükakin||Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte|