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http://hdl.handle.net/11375/20112
Title: | COLCHICINE FOR PREVENTION OF PERIOPERATIVE ATRIAL FIBRILLATION IN PATIENTS UNDERGOING THORACIC SURGERY: PILOT STUDY |
Authors: | Bessissow, Amal |
Advisor: | Devereaux, P.J. Bhandari, Mohit Lamy, Andre |
Department: | Health Research Methodology |
Publication Date: | 2016 |
Abstract: | BACKGROUND: Up to 20% of patients will develop postoperative atrial fibrillation (POAF) or atrial flutter after thoracic surgery. These arrhythmias have been associated with serious complications such as death, stroke, and increased hospital length of stay. OBJECTIVES: This study aimed to determine: the feasibility of recruiting patients undergoing thoracic surgery to a randomized controlled trial (RCT) comparing colchicine and placebo for the prevention of POAF, the resources required to conduct a large trial, and compliance with the study drug. The main efficacy outcome was POAF or atrial flutter within 30 days of randomization. METHODS: Patients aged 55 years and older undergoing a resection of tumor in the lung were recruited from two Canadian centers. Participants were randomly assigned to receive colchicine 0.6mg or placebo orally within 4 hours before surgery. Postoperatively, patients received colchicine 0.6mg or placebo twice daily for 10 days. Troponin measurement and an electrocardiogram were performed daily during the first 3 days after surgery. Patients’ follow-up occurred in hospital and at 30-days. RESULTS: One hundred patients were randomized (49 to colchicine and 51 to placebo) over a period of 12 months. All patients completed the 30-day follow-up. The mean staff time required to recruit and follow-up each patient was 165 minutes. 71% of patients completed the study drug course without interruption. New POAF or atrial flutter occurred in 5 (10.2%) of the patients in the colchicine group and 7 (13.7%) of the patients in the placebo group (adjusted hazard ratio 0.69; 95% confidence interval, 0.20-2.34; p= 0.55). CONCLUSION: These results show the feasibility of COP-AF pilot study. This pilot study will serve as the foundation for the large multicentre COP-AF RCT. |
URI: | http://hdl.handle.net/11375/20112 |
Appears in Collections: | Open Access Dissertations and Theses |
Files in This Item:
File | Description | Size | Format | |
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Bessissow_Amal_finalsubmission2016July_MSc.pdf | Master's thesis manuscript | 992.59 kB | Adobe PDF | View/Open |
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