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Clinical Trials/ACTRN12621000543886
ACTRN12621000543886
Recruiting
Phase 2

A randomized controlled trial investigating the effect of pre-operative melatonin on the extend of ischemic-reperfusion injury in adult patients undergoing coronary artery bypass grafting (CABG) surgery.

Sir Charles Gairdner Hospital0 sites114 target enrollmentMay 10, 2021
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Conditionsmyocardial reperfusion injuryoxidative damageinflammationCardiovascular - Coronary heart diseaseCardiovascular - Other cardiovascular diseases

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
myocardial reperfusion injury
Sponsor
Sir Charles Gairdner Hospital
Enrollment
114
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 10, 2021
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Aged between 18 and 90 years.
  • •2\.Undergoing elective cardiac surgery, requiring cardiopulmonary bypass (coronary artery bypass grafting (CABG)) at Sir Charles Gairdner Hospital and Saint John of God Subiaco.
  • •3\.Being willing and able to provide informed consent.

Exclusion Criteria

  • •Patients will be ineligible for study entry if they have concomitant hepatic failure, an autoimmune disease or the inability to give informed consent. Patients on immunosuppressive drugs, oral contraceptives, fluvoxamine, and those consuming melatonin within two weeks before the operation, will also be excluded.
  • •The exclusion criteria further includes patients who are pregnant, breastfeeding, and those requiring urgent or emergency surgery (resulting in insufficient time to take melatonin).

Outcomes

Primary Outcomes

Not specified

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