evaluation of colchicine for the Prevention of the Post-pericardiotomy Syndrome (COPPS):

Phase 3

Conditions: Post-pericardiotomy Syndrome.
Disease of pericardium, unspecified
I31.9

Registration Number: IRCT20120703010178N21

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 100

Inclusion Criteria

All patients undergoing cardiac surgery, had no contraindication to colchicine, were able to provide informed consent.
candidate for cardiac surgery by cardiologist
age =18 years
patients have to be willing and able to give informed consent and to comply with the study and follow-up.

Exclusion Criteria

known myopathy or elevated baseline pre-operative creatine kinase
Liver problems
serum creatinine upper than 2.5mg/dl
Gastrointestinal problems
pregnancy or OCP usage
hypersensitivity to colchicine

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence of post-pericardiotomy syndrome ( PPS):. Timepoint: 2 days before surgery,till 2weeks ,after it. Method of measurement: physical examination-echocardiography PPS confirms when at least two of the following parameters occur simultaneously: 1- Fever: 2-3 weeks post-operative without evidence of systemic or focal infection; 2- Pleuritic chest pain; 3-Friction rub; 4- Evidence of pleural or pericardial effusion.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint was the combined rate of disease-related rehospitalization, cardiac tamponade, constrictive pericarditis,and recurrent pericarditis. Timepoint: During first 14 days after cardiac surgery or hospitalization period. Method of measurement: echocardiography-physical examination.