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Melatonin and Cardiac Outcome After Major Surgery

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ClinicalTrials.gov Identifier: NCT00315926
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : June 30, 2010
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen

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 surgery.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm Drug: Melatonin Drug: Placebo Phase 2 Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair
Study Start Date : January 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Melatonin Drug: Melatonin
Melatonin 50 mg during surgery and 10 mg every night for 3 nights

Placebo Comparator: Placebo Drug: Placebo
a mixture of ethanol and physiological saline




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315926


Locations
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Denmark
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
Hellerup, Denmark
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
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Principal Investigator: Bülent Kücükakin Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

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Responsible Party: Dr. Bülent Kücükakin, dept. of surgery, Gentofte Hospital, Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT00315926     History of Changes
Other Study ID Numbers: 2612-3109
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: June 30, 2010
Last Verified: November 2006

Keywords provided by University Hospital, Gentofte, Copenhagen:
Cardiac morbidity
Melatonin
Surgery
Postoperative

Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants