NCT00315926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 30, 2010

Status Verified

November 1, 2006

Enrollment Period

1.5 years

First QC Date

April 18, 2006

Last Update Submit

June 29, 2010

Conditions

Aortic Aneurysm

Keywords

Cardiac morbidityMelatoninSurgeryPostoperative

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Oxidative and inflammatory stress response

    3 days

Study Arms (2)

Melatonin

EXPERIMENTAL
Drug: Melatonin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MelatoninDRUG

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

Melatonin
PlaceboDRUG

a mixture of ethanol and physiological saline

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for elective abdominal aortic aneurism surgery or periphery atheroscleroses with indicated protheses operation
  • Patients between 18 and 80 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

Hellerup, Denmark

Location

MeSH Terms

Conditions

Aortic Aneurysm

Interventions

Melatonin

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Bülent Kücükakin

    Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 19, 2006

Study Start

January 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 30, 2010

Record last verified: 2006-11

Locations

DK(1)