Colchicine to reduce arrhythmia in the postoperative period of cardiac surgery

Not Applicable

• Conditions: Atrial fibrillation, Chronic ischemic heart disease; C14.280.067.198; C14.280.647

• Registration Number: RBR-556dhr
• Lead Sponsor: Hospital Santa Casa de Misericórdia de Curitiba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients were recruited willing and able to provide informed consent and in accordance with the study procedures. All aged greater than or equal to 18 years; indication for elective coronary artery bypass grafting; sinus rhythm on the day preceding surgery. The mean age was 60.3 ± 8.1 years in the control group and 61.5 ± 10.3 years in the colchicine group (p = 0.44), 45 participants were female and 95 male. The sample size was 140 patients

Exclusion Criteria

Exclusion criteria were: contraindication for use of study medication; atrial fibrillation or atrial flutter previously diagnosed; need for associated valve surgery; severe liver disease (transaminases above 1.5 times normal); renal failure (creatinine> 2 mg / dl); gastrointestinal diseases known; current treatment with colchicine; cardiogenic shock; severe arrhythmias; neoplasms; patients not communicative; Simultaneous use of antiarrhythmic drugs, excluding digoxin, beta-blockers and calcium channel blockers.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary study endpoint was the rate of atrial fibrillation in the postoperative period of myocardial revascularization. For the current study, the 140 patients, 69 in the control group and 71 in the intervention group were needed to detect an FA rate of 20% and 6% (control and colchicine), with a power of 80% and using p = 0.05 in the two treatment groups. The determination of the estimated rates of FA for the two groups were based on the results of a placebo-controlled randomized study in which the FA rate was significantly lower in the colchicine group compared to the placebo group (12% versus 22%, respectively, p = 0.021);The patients in the colchicine group showed no reduction in the incidence of atrial fibrillation compared to the control group (13.04% versus 7.04%, control and colchicine, respectively; p = 0.271)

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are not expected