Status:
COMPLETED
Melatonin and Cardiac Outcome After Major Surgery
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Aortic Aneurysm
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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 surge...
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 spec...
Eligibility Criteria
Inclusion
- Indication for elective abdominal aortic aneurism surgery or periphery atheroscleroses with indicated protheses operation
- Patients between 18 and 80 years old
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00315926
Start Date
January 1 2007
End Date
July 1 2008
Last Update
June 30 2010
Active Locations (1)
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1
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
Hellerup, Denmark