Overview

Study of Colchicine to Prevent the Postpericardiotomy Syndrome

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Azienda Sanitaria Locale 3, Torino
Treatments:
Colchicine
Criteria
Inclusion Criteria:

- Patients in the third day after a cardiac surgery operation

- Ageā‰„ 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