Cardiac Surgery and the Risk of Atrial Fibrillation: an Intervention Trial Evaluating Melatonin
Status:
Withdrawn
Trial end date:
2015-07-06
Target enrollment:
Participant gender:
Summary
Atrial fibrillation is a common heart rhythm condition that can occur after cardiac surgery
and has been associated with an increase in hospital length of stay, overall hospital costs,
worsening clinical condition and higher rates of death. Newer research indicates that
inflammation is a key contributor to atrial fibrillation in this setting.
Melatonin is a naturally made hormone that is regarded as an extremely effective
anti-inflammatory substance, with a very favorable safety profile. This clinical trial is
being done to test the ability of melatonin to reduce the risk of developing atrial
fibrillation after cardiac surgery.
This is a research study where patients will be given either oral melatonin at 40 mg or
placebo nightly prior to sleep. The study product will start approximately 2 days prior to
the scheduled surgery date and will continue until the 3rd day after the operation. The
remainder of the clinical care will remain the same.
The investigators project that patients who receive melatonin will have a significant
decrease in the occurrence of atrial fibrillation after surgery.