COlchicine in Cardiac Surgery

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Postoperative atrial fibrillation (POAF) is a major complication of cardiac surgery, which could lead to high morbidity and mortality, increase duration of hospital stay and increase the cost of treatment. Colchicine possesses both anti-inflammatory and sympatholytic properties, so it has been studied to prevent POAF. The ACC/AHA guidelines for colchicine contain a class IIB recommendation, but the ESC guidelines do not recommend this drug. More researches are needed to focus on reducing of side effects by optimizing the colchicine regimen to reduce the incidence of gastrointestinal side effects. It is believed that further research is needed to investigate the efficacy and safety of colchicine in these conditions.

This research is aimed to study the effectiveness of short-term administration of the drug.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bakulev Scientific Center of Cardiovascular Surgery
• Treatments: Colchicine

Criteria

Inclusion Criteria:

Adult patients awaiting elective cardiac surgery (CABG and/or AVR (aortic valve replacement), who are willing and able to give informed consent for participation in the study and who are in sinus rhythm and not taking any antiarrhythmic medication, except beta-adrenergic blocking agents, at the time before surgery.

Exclusion Criteria:

• History of persistent or long-term atrial fibrillation/atrial flutter

• Congenital heart disease, except the bicuspid AV

• Frequent VE/SVE, AV block 2-3 degrees

• Use of corticosteroids during the last month

• Taking any antiarrhythmic drugs, except beta-blockers, within the last 1 month

• Prior "open" heart surgery

• Moderate to severe renal failure (creatinine clearance < 50 ml / min)

• History of obstructive hepato-biliary disease or other serious hepatic disease

• Significant mitral valve disease (moderate or severe mitral regurgitation-eg. > grade II and/or mitral stenosis & mitral annular calcification).

• Patient participation in another clinical trial