Melatonin and Cardiac Outcome After Major Surgery

Aortic Aneurysm Clinical Trial

Official title:

Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315926
• Other study ID #: 2612-3109
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 18, 2006
• Last updated: June 29, 2010
• Start date: January 2007
• Est. completion date: July 2008

Study information

• Verified date: November 2006
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm

Intervention

Drug:
• Melatonin
Melatonin 50 mg during surgery and 10 mg every night for 3 nights
• Placebo
a mixture of ethanol and physiological saline

Locations

Country	Name	City	State
Denmark	Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac morbidity	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.	30 days	Yes
Secondary	Oxidative and inflammatory stress response	Blood samples for analysis of malondialdehyde (MDA), ascorbic acid (AA), dehydroascorbic acid (DHA) and C-reactive protein (CRP) assessed before and after operation	3 days	No