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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00315926 |
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Date of registration:
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18/04/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Melatonin and Cardiac Outcome After Major Surgery
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Scientific title:
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Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair |
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Date of first enrolment:
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January 2007 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00315926 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Bülent Kücükakin |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aortic Aneurysm
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Intervention(s)
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Drug: Melatonin
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Drug: Placebo
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Primary Outcome(s)
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Cardiac morbidity
[Time Frame: 30 days]
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Secondary Outcome(s)
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Oxidative and inflammatory stress response
[Time Frame: 3 days]
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Secondary ID(s)
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2612-3109
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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