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Melatonin and Cardiac Outcome After Major Surgery

NCT ID: NCT00315926

Last Updated: 2010-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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Aortic Aneurysm

Keywords

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Cardiac morbidity Melatonin Surgery Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Melatonin

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

Melatonin 50 mg during surgery and 10 mg every night for 3 nights

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

a mixture of ethanol and physiological saline

Interventions

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Melatonin

Melatonin 50 mg during surgery and 10 mg every night for 3 nights

Intervention Type DRUG

Placebo

a mixture of ethanol and physiological saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Gentofte Hospital, Copenhagen, Denmark

Principal Investigators

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Bülent Kücükakin

Role: PRINCIPAL_INVESTIGATOR

Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

Locations

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Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2612-3109

Identifier Type: -

Identifier Source: org_study_id