Steroids In caRdiac Surgery Trial

• Conditions: adult patients with coronary artery disease and/or valvular diseaserequiring cardiac surgery with the use of cardiopulmonary bypass.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-023093-39-ES
• Lead Sponsor: Institut de Recerca Hospital Sant Pau

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-09
• Last Update Posted: 7 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 7500

Inclusion Criteria

1. Age more or equal to 18 years
2. Require CPB for any cardiac surgical procedure (such as CABG,
Valve, Aorta, or combined procedures)
3. EuroScore greater than or equal to 6
4. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4500

Exclusion Criteria

1. Use of systemic steroids or will undergo planned systemic steroid
therapy in the immediate postoperative period (e.g. cardiac
transplantation)
2. History of bacterial or fungal infection in the last 30 days
3. Allergy or intolerance to corticosteroids
4. Receiving Aprotinin
5. Previous participation in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified