Study of Colchicine to Prevent the Postpericardiotomy Syndrome

Azienda Sanitaria Locale 3, Torino360 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

360

Conditions

Postpericardiotomy Syndrome

Interventions

Colchicine (for 1 month)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Ospedali Riuniti

Bergamo, Bergamo, Italy

Ospedale Regionale Bolzano

Bolzano, Bolzano, Italy

Ospedale Niguarda

Milan, Milano, Italy

Cardiology Department. Maria Vittoria Hospital. ASL 3. Torino.

Torino, Torino, Italy

Outcomes

Primary Outcomes

Postpericardiotomy syndrome

Time frame: 12 months

Secondary Outcomes

Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses

Data from ClinicalTrials.gov

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