Cochicine Treatment for Post- Operative Pericardial Effusion

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: The incidence of asymptomatic pericardial effusion is high after cardiac surgery.

Objective: To assess whether colchicine is effective in reducing post operative pericardial effusion volume.

Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention :

colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by echocardiography) more than 7 days after cardiac surgery.

Measurements: The main end point will be change in effusion grade after 14 days of treatment. Secondary endpoints include frequency of late cardiac tamponade.

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

Details

• Lead Sponsor: French Cardiology Society
• Collaborator: French Federation of Cardiology
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• patients with recent cardiac surgery

• admitted for cardiac rehabilitation

• pericardial effusion > grade 2 (corresponds to a loculated effusion > 10 millimeters or a circumferential effusion of any size)on the first trans thoracic echocardiography performed more than 7 days after surgery

Exclusion Criteria:

• patients who do not give written consent to participate

• pregnancy

• colchicine allergy;

• renal failure, which we define as a serum creatinine level > 250micromol/l or clairance < 30 ml/mn

• heart transplantation,or correction of congenital heart anomalies cardiac surgery more than 30 days before their first trans thoracic echocardiography pericardial effusion that requires immediate drainage.