Study of Colchicine to Prevent the Postpericardiotomy Syndrome

Phase 3

Completed

• Conditions: Postpericardiotomy Syndrome

• Registration Number: NCT00128427
• Lead Sponsor: Azienda Sanitaria Locale 3, Torino

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 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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-08-08
• Study First Submitted QC: 2005-08-08
• Study First Posted: 2005-08-10
• Status Verified: 2010-06
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Last Update Submitted: 2010-06-13
• Last Update Posted: 2010-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postpericardiotomy syndrome	12 months

Secondary Outcome Measures

Name	Time	Method
Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses

Trial Locations

Locations (6)

Ospedale Niguarda; 🇮🇹 Milano, Italy

Ospedali Riuniti; 🇮🇹 Bergamo, Italy

Ospedale Regionale Bolzano; 🇮🇹 Bolzano, Italy

Ospedale di Rivoli; 🇮🇹 Rivoli, Italy

Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.; 🇮🇹 Torino, Italy

Cardiac Surgery- Ospedale Mauriziano; 🇮🇹 Torino, Italy