Steroids in Cardiac Surgery (SIRS) trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001495-18-BE

Enrollment

7500

Registered

2011-07-26

Start date

2011-08-23

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac surgery

Interventions

Trade Name: Solu-Medrol Product Name: Solu-Medrol Pharmaceutical Form: Injection INN or Proposed INN: methylprednisolone CAS Number: H02AB04 Concentration unit: mg milligram(s) Concentration type: equ

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 6-month all-cause mortality in high-risk patients 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 hospital discharge of on postoperative day 4 whichever comes first 30 days postoperative;Main Objective: To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 30-day all-cause mortality in high-risk patients	—

Measure

Time frame

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 To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 6-month all-cause mortality in high-risk patients 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 hospital discharge of on postoperative day 4 whichever comes first 30 days postoperative;Main Objective: To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 30-day all-cause mortality in high-risk patients

—

Secondary

Measure	Time frame
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 hospital discharge of on postoperative day 4 whichever comes first 30 days postoperative	—

Countries

Australia, Belgium, Canada, United States

Contacts

Public ContactJessica Vincent

Population Health Research Institute

jessica.vincent@phri.ca9055274322

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026