SIRS Steroids In caRdiac Surgery Trial - SIRS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000591-34-IE

Enrollment

3750

Registered

2011-03-15

Start date

2011-05-06

Completion date

Unknown

Last updated

2025-03-17

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

Conditions

Study Objective(s) To determine whether high-risk patients undergoing cardiac surgery requiring CPB derive benefit from perioperative steroids. Study Design Multicentre, International, randomized, double-blind placebo-controlled trial of high-risk adult patients undergoing cardiopulmonary bypass.

Interventions

Trade Name: solu-medrone Pharmaceutical Form: Injection Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether high-risk patients undergoing cardiac surgery requiring CPB derive benefit from perioperative steroids. The primary objective of this study is to evaluate if methylprednisolone given before cardiopulmonary bypass reduces 30-day all-cause mortality in high-risk patients. ;Secondary Objective: Secondary Objectives 2. To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 6-month all-cause mortality in high-risk patients 3. To evaluate if methylprednisolone given before cardiopulmonary bypass reduces postoperative morbidity related to atrial fibrillation, bleeding, delirium, blood transfusions, and length of stay in high-risk patients 4. To evaluate the safety of methylprednisolone. Assessment of the impact on infections, gastrointestinal, and wound complications. ;Primary end point(s): Primary Outcome The incidence of death at 30 days.	—

Measure

Time frame

Main Objective: To determine whether high-risk patients undergoing cardiac surgery requiring CPB derive benefit from perioperative steroids. The primary objective of this study is to evaluate if methylprednisolone given before cardiopulmonary bypass reduces 30-day all-cause mortality in high-risk patients. ;Secondary Objective: Secondary Objectives 2. To evaluate if methylprednisolone given before cardiopulmonary bypass reduces 6-month all-cause mortality in high-risk patients 3. To evaluate if methylprednisolone given before cardiopulmonary bypass reduces postoperative morbidity related to atrial fibrillation, bleeding, delirium, blood transfusions, and length of stay in high-risk patients 4. To evaluate the safety of methylprednisolone. Assessment of the impact on infections, gastrointestinal, and wound complications. ;Primary end point(s): Primary Outcome The incidence of death at 30 days.

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Countries

Ireland

Outcome results

None listed

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