Study of Colchicine to Prevent the Postpericardiotomy Syndrome

City of Turin Local Health Authority

Status and phase

Completed

Phase 3

Conditions

Postpericardiotomy Syndrome

Treatments

Drug: Colchicine (for 1 month)

Study type

Interventional

Funder types

Other

Identifiers

NCT00128427

EUDRACT number 2005-001570-28

DCASL30501-3

Details and patient eligibility

About

The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.

Full description

The postpericardiotomy syndrome is a frequent complication after cardiac surgery affecting from 20 to 40% of patients. The etiology of this complication is a subject of debate. It is commonly believed to be an autoimmune response to pericardial and/or pleural bleeding or surgical trauma. Colchicine is safe and effective in the treatment and prevention of pericarditis and preliminary data have shown that it may be effective also in the primary prevention of the postpericardiotomy syndrome.

Comparisons: The study will compare the safety and efficacy of colchicine in the primary prevention of the postpericardiotomy syndrome in addition to optimal standard care.

Enrollment

360 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients in the third day after a cardiac surgery operation
Age≥ 18 years
Informed consent

Exclusion criteria

All evaluated before the surgical operation:

Known severe liver disease and/or elevated transaminases >1.5 times the upper limit of normality
Serum creatinine >2.5 mg/dl
Serum creatine kinase (CK) over the upper limit of normality or known myopathy
Known gastrointestinal or blood disease
Pregnant or lactating women or women not protected by a contraception method
Known hypersensibility to colchicine
Treatment with colchicine at enrolment