NCT00315926

Melatonin and Cardiac Outcome After Major Surgery

Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University Hospital, Gentofte, Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Aortic Aneurysm

Interventions

Type	Name	Description
DRUG	Melatonin	Melatonin 50 mg during surgery and 10 mg every night for 3 nights
DRUG	Placebo	a mixture of ethanol and physiological saline

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2006-04-19
• Last updated: 2010-06-30

Locations

1 site across 1 country: Denmark