Steroids in Cardiac Surgery (SIRS) trial

Conditions: cardiac surgery
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2011-001495-18-BE

Lead Sponsor: Population health Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 7500

Inclusion Criteria

age >= 18 years
reqyire =CPB for any cardiac surgical procedure
EuroScore >= 6
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

use of systemic steroids or will undergo planned systemic steroid therapy in the immediate postoperative period
History of bacterial or fungal infection in the last 30 days
allergy or intolerance to corticosteroids
Receiving aprotinin
previous participation in this study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: to evaluate if methylprednisolone given before cardiopulmonary bypass reduces postoperative morbidity related to atrial fibrillation, bleeding, delirium, blood transfusions and length of sty in high-risk patients<br><br>To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 6-month all-cause mortality in high-risk patients<br><br>to evaluate the safety of methylprednisolone. Assessemnt of the impact on infections, gastrointestinal and wound cimplications.;Primary end point(s): The incidence of death at 30 days;Timepoint(s) of evaluation of this end point: 24 hours postoperative<br>hospital discharge of on postoperative day 4 whichever comes first<br>30 days postoperative;Main Objective: To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 30-day all-cause mortality in high-risk patients

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The incidence of a composite of significant myocardial injury or death at 30 days;Timepoint(s) of evaluation of this end point: 24 hours postoperative<br>hospital discharge of on postoperative day 4 whichever comes first<br>30 days postoperative