Melatonin and Cardiac Outcome After Major Surgery

Last updated: June 29, 2010
Sponsor: University Hospital, Gentofte, Copenhagen
Overall Status: Completed

Phase

2/3

Condition

Heart Disease

Aneurysm

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT00315926
2612-3109
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Indication for elective abdominal aortic aneurism surgery or periphery atheroscleroseswith indicated protheses operation

  • Patients between 18 and 80 years old

Exclusion

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

Study Design

Total Participants: 52
Study Start date:
January 01, 2007
Estimated Completion Date:
July 31, 2008

Study 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.

Connect with a study center

  • Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

    Hellerup,
    Denmark

    Site Not Available

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