Melatonin and Cardiac Outcome After Major Surgery

Phase 2

Completed

• Conditions: Aortic Aneurysm
• Interventions: Drug: Placebo; Drug: Melatonin

• Registration Number: NCT00315926
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2006-04-18
• Study First Submitted QC: 2006-04-18
• Study First Posted: 2006-04-19
• Status Verified: 2006-11
• Study Start: 2007-01
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Last Update Submitted: 2010-06-29
• Last Update Posted: 2010-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Melatonin	Melatonin	-

Primary Outcome Measures

Name	Time	Method
Cardiac morbidity	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

Name	Time	Method
Oxidative and inflammatory stress response	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

Trial Locations

Locations (1)

Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte; 🇩🇰 Hellerup, Denmark