Cochicine Treatment for Post- Operative Pericardial Effusion
- Conditions
- Pericardial Effusion
- Interventions
- Drug: PlaceboDrug: Colchicines
- Registration Number
- NCT01266694
- Lead Sponsor
- French Cardiology Society
- Brief 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.
- Detailed Description
Clinically insignificant pericardial effusion is common after heart surgery with an incidence of 50 % to 85 % a few days after surgery Cardiac tamponade occurs in about 1-2 % of patients who undergo cardiac surgery and may develop slowly without clear-cut clinical signs. Most tamponade occurs more than 7 days after surgery which is a concern because, at that time, patients often have already been discharged from the hospital.
No study has ever shown the efficacy any drug for this condition.In particular, we published a study demonstrating the absence of efficacy of a non steroidal anti inflammatory drug (Meurin P, Tabet JY, Thabut G, et al.French Society of Cardiology. Nonsteroidal anti-inflammatory drug treatment for postoperative pericardial effusion: a multicenter randomized, double-blind trial. Ann Intern Med. 2010 Feb2;152(3):137-43) Cochicine is widely used to treat inflammatory pericarditis ; is it efficient to treat post operative pericardial effusions ? this is the question we want to answer to.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 199
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo patients placebo controlled Cochicine Colchicines Colchicine arm: patient receiving 1 mg per day for 14 days
- Primary Outcome Measures
Name Time Method change in effusion grade 14 days
- Secondary Outcome Measures
Name Time Method frequency of late cardiac tamponade 14 days number of patients with at least a one-grade decrease in the effusion 14 days mean change in the width of the effusion measured in millimeters 14 days evolution of prespecified subgroups 14 days * patients with inflammatory syndrom : crp \> 30 mg/l
* patients receiving an anticoagulant
* patients with a post pericardiotomy syndrom
Trial Locations
- Locations (10)
Bois Gibert
🇫🇷Ballan Miré, France
Clinique Iris
🇫🇷Marcy l'étoile, France
Centre Médical de Bligny
🇫🇷Briis sous Forges, France
Clinique de Châtillon
🇫🇷Châtillon, France
Hopital Corentin Celton
🇫🇷Issy les moulineaux, France
Centre Dieulefit Santé
🇫🇷Dieulefit, France
Clinique de la mitterie
🇫🇷Lomme, France
Clinique les Grands Près
🇫🇷Villeneuve Saint Denis, France
Centre Hospitalier Loire Vendée Océan
🇫🇷Machecoul, France
Maison du mineur
🇫🇷Vence, France