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Melatonin and Cardiac Outcome After Major Surgery

Primary Purpose

Aortic Aneurysm

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aortic Aneurysm focused on measuring Cardiac morbidity, Melatonin, Surgery, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2006
Last Updated
June 29, 2010
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00315926
Brief Title
Melatonin and Cardiac Outcome After Major Surgery
Official Title
Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm
Keywords
Cardiac morbidity, Melatonin, Surgery, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
Melatonin 50 mg during surgery and 10 mg every night for 3 nights
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
a mixture of ethanol and physiological saline
Primary Outcome Measure Information:
Title
Cardiac morbidity
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Oxidative and inflammatory stress response
Description
Blood samples for analysis of malondialdehyde (MDA), ascorbic acid (AA), dehydroascorbic acid (DHA) and C-reactive protein (CRP) assessed before and after operation
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bülent Kücükakin
Organizational Affiliation
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
City
Hellerup
Country
Denmark

12. IPD Sharing Statement

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Melatonin and Cardiac Outcome After Major Surgery

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