Melatonin and Cardiac Outcome After Major Surgery

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Gentofte, Copenhagen

ClinicalTrials.gov Identifier:

NCT00315926

First received: April 18, 2006

Last updated: June 29, 2010

Last verified: November 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

April 18, 2006

Last Updated Date

June 29, 2010

Start Date ^ICMJE

January 2007

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cardiac morbidity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00315926 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Oxidative and inflammatory stress response [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Blood samples for analysis of malondialdehyde (MDA), ascorbic acid (AA), dehydroascorbic acid (DHA) and C-reactive protein (CRP) assessed before and after operation

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Melatonin and Cardiac Outcome After Major Surgery

Official Title ^ICMJE

Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair

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 Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Aortic Aneurysm

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Melatonin
Intervention: Drug: Melatonin
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00315926

Other Study ID Numbers ^ICMJE

2612-3109

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Bülent Kücükakin, dept. of surgery, Gentofte Hospital, Copenhagen, Denmark

Study Sponsor ^ICMJE

University Hospital, Gentofte, Copenhagen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Bülent Kücükakin

Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

Information Provided By

University Hospital, Gentofte, Copenhagen

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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