Status:
COMPLETED
Study of Colchicine to Prevent the Postpericardiotomy Syndrome
Lead Sponsor:
Azienda Sanitaria Locale 3, Torino
Conditions:
Postpericardiotomy Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.
Detailed 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...
Eligibility Criteria
Inclusion
- Patients in the third day after a cardiac surgery operation
- Age≥ 18 years
- Informed consent
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00128427
Start Date
June 1 2005
End Date
June 1 2010
Last Update
June 15 2010
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedali Riuniti
Bergamo, Bergamo, Italy
2
Ospedale Regionale Bolzano
Bolzano, Bolzano, Italy
3
Ospedale Niguarda
Milan, Milano, Italy
4
Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.
Torino, Torino, Italy, 10141