None listed
Conditions
Brief summary
The purpose of this study is to conduct a prospective double blind placebo randomized control trial to evaluate the effect of colchicine in preventing postoperative atrial fibrillation after cardiac surgery.
Interventions
Colchicine 0.5 mg oral twice daily for 7 days or until discharge (whichever occurs sooner).
Sponsors
Barwon Health - The Geelong Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Isolated CABG 2. Isolated AVR 3. CABG and AVR 4. Able and willing to give informed consent 5. Able to comply with study procedures 6. No prior history of paroxysmal, persistent, permanent AF 7. In sinus rhythm at time of randomization 8. eGFR greater or equal to 35 ml/min at time of randomisation 9. Liver Transaminase (AST or ALT) less than 3 times the upper limit of normal at time of randomisation. 10. Extubated within 72 hours post-operatively and able to tolerate oral intake 11. Age older than 18 years
Exclusion criteria
1. Known hypersensitivity to colchicine 2. Current treatment with colchicine 3. Known severe liver disease or current transaminases greater than three times the upper normal limit 4. Current eGFR less than 35 ml/min 5. Known myopathy or elevated baseline preoperative creatinine kinase (CK) not attributable to their medical condition 6. Known blood dyscrasias with abnormal preoperative Full Blood Examination (FBE) not attributable to their medical condition 7. Known severe gastrointestinal disease 8. Pregnant women, lactating women, or women of childbearing age. 9. Patients with known paroxysmal, persistent, or chronic AF 10. Patients extubated after 72 hours of their ICU admission post-operatively 11. Unable to tolerate oral intake
Outcome results
None listed