Melatonin and Cardiac Outcome After Major Surgery

Sponsor

University Hospital, Gentofte, Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT00315926

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2007

Actual Primary Completion Date :

Jul 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Indication for elective abdominal aortic aneurism surgery or periphery atheroscleroses with indicated protheses operation
Patients between 18 and 80 years old