None listed
Conditions
Brief summary
Heart disease is the leading cause of death worldwide. The only way to lessen the detrimental effects on the heart during oxygen poor circumstances is to re-introduce oxygen to the cells of the heart (by getting rid of the obstruction responsible for the problem). Re-introduction of blood flow and oxygen to cells that was oxygen poor however also results in damage to the cells. This is known as “reperfusion injury”, the medical world still doesn’t have a treatment option to eliminate reperfusion injury. The aim of this study is to investigate a new treatment option (melatonin) to lessen or eliminate the damage to the heart following reperfusion injury. Although we know that this treatment option is extremely effective in animals (it halved the size of heart attacks in rats), we still don’t have a clear answer to its role in humans. More research is required to determine how melatonin can benefit patients undergoing heart surgery. We thus hypothesize that preoperative, sublingual melatonin will have cardio-protective properties during reperfusion injury, and that the cardio-protection will be as a result of the anti-oxidant and anti-inflammatory effects associated with melatonin supplementation. The degree of cardio-protection, anti-inflammatory and anti-oxidative properties will be assessed by biomarkers (CRP and hsTnT levels found in blood samples). This study will be performed at two centres (Sir Charles Gairdner Hospital and Saint John of God, Subiaco) and is a prospective, randomized, double-blind, placebo-controlled, phase 2 study investigating the oral, preoperative administration of melatonin. Double-blind means that neither you nor your study doctor will know which treatment you are receiving. This research project has specifically been designed this way to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions. However, in the event it is medically necessary your study doctor can find out which treatment you are receiving. The participants will be allocated into three study groups: The control group (receiving placebo with no active ingredients), the low dose melatonin group and the higher dose melatonin group.
Interventions
This study will consist of three groups, the group a participant is allocated to will dictate whether he/she receives placebo, higher or low dose melatonin. Low dose of melatonin being 10mg, higher dose of melatonin being 30mg and placebo will be a tablet with no active ingredients. The study medications will be visually identical and placed in identical envelopes labelled either A, B or C. All participants will receive a once-off sublingual tablet, taken orally 20minutes before surgery. The rel
This study will consist of three groups, the group a participant is allocated to will dictate whether he/she receives placebo, higher or low dose melatonin. Low dose of melatonin being 10mg, higher dose of melatonin being 30mg and placebo will be a tablet with no active ingredients. The study medications will be visually identical and placed in identical envelopes labelled either A, B or C. All participants will receive a once-off sublingual tablet, taken orally 20minutes before surgery. The relevant tablet will be administered to the participant under direct supervision of one of the investigators, and individual pre-operative, intra-operative and post-operative plasma melatonin levels monitored.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
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).
Outcome results
None listed