Post-pericardiotomy Syndrome. Disease of pericardium, unspecified
Conditions
Interventions
Intervention 1: Forty-eight hours before surgery, subjects in the intervention group will receive colchicine (Modava pharmaceuticals, Iran) two tablets (equal to 1mg colchicine) every 12 hours for 48
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Sistanizad
Shahid Beheshti University of Medical Sciences
Outcome results
None listed