Atrial Fibrillation, Cardiac Surgery, Pericardial Effusion, Pleural Effusion, Post-pericardiotomy Syndrome
Conditions
Keywords
cardiac surgery, post-pericardiotomy syndrome, atrial fibrillation, pericardial effusion, pleural effusion, prevention, colchicine
Brief summary
This is a multicenter, double-blind, randomized trial to assess the efficacy and safety of colchicine for post-pericardiotomy syndrome prevention, post-operative effusions prevention, and post-operative atrial fibrillation prevention.
Detailed description
This is a multi center, double-blind, randomized trial to test the efficacy and safety of colchicine for prevention of post-pericardiotomy syndrome, post-operative effusions, and post-operative atrial fibrillation.
Interventions
DRUGColchicine
Colchicine 0.5 mg BID or colchicine 0.5mg (\<70kg) 48 to 72 hours before surgery till 1 months after surgery
DRUGPlacebo
Placebo 48 to 72 hours before surgery till 1 months after surgery
Sponsors
Maria Vittoria Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18years * Candidate to cardiac surgery but cardiac transplantation * Informed consent
Exclusion criteria
* Atrial fibrillation * Candidate to cardiac transplantation * Severe liver disease or elevation of serum transaminases (\> 1.5 times the upper reference limit) * Serum creatinine \> 2.5 mg/dL * Preoperative elevation of CK or known myopathy * Known chronic intestinal diseases or blood dyscrasias * Pregnancy, Lactation or Women of childbearing potential not protected by a contraception method * Hypersensitivity to colchicine * Treatment with colchicine for any cause
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence | 3 months | Incidence of the outcomes at 3 months from cardiac surgery |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence of the post-pericardiotomy syndrome | 3 months |
| Re-admission | 3 months |
| Need for thoracentesis | 3 months |
| Stroke incidence | 3 months |
| Cardiac Tamponade or Need for Pericardiocentesis | 3 months |
| Overall mortality | 3 months |
Countries
Italy
Outcome results
None listed