Melatonin and Cardiac Outcome After Major Surgery

June 29, 2010 updated by: University Hospital, Gentofte, Copenhagen

Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark
        • Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
a mixture of ethanol and physiological saline
Experimental: Melatonin
Drug: Melatonin
Melatonin 50 mg during surgery and 10 mg every night for 3 nights

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac morbidity
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxidative and inflammatory stress response
Time Frame: 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
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Bülent Kücükakin, Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria

April 18, 2006

First Posted (Estimate)

April 19, 2006

Study Record Updates

Last Update Posted (Estimate)

June 30, 2010

Last Update Submitted That Met QC Criteria

June 29, 2010

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2612-3109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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