Steroids In caRdiac Surgery Trial

SIRS Steroids In caRdiac Surgery Trial - SIRS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001099-21-AT

Enrollment

7500

Registered

2011-04-07

Start date

2011-05-19

Completion date

Unknown

Last updated

2016-12-12

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

Conditions

From available evidence, corticosteroids attenuate the inflammatory response to CPB which is felt to contribute to morbidity and mortality in cardiac surgery patients. The meta-analysis of the literature demonstrates a trend toward reduced risk of death in patients receiving steroid treatment, RR of 0.73, CI of 0.45 to 1.18, which, if real, would have enormous global impact.

Interventions

Trade Name: Urbason Pharmaceutical Form: Concentrate and solvent for injection CAS Number: 83-43-2 Other descriptive name: Methylprednisolon Concentration unit: mg milligram(s) Concentration type: equ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >= 18 require CPB for any cardiac surgical procedure EuroScore greater than or equal 6 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: systemic steroids or will undergo systemic steroid therapy bacterial fungal infection in last 30 days allergy or intolerance to corticosteroids Aprotinin

Design outcomes

Primary

Measure	Time frame
Main Objective: Methylprednisolon given before cardiopulmonary bypass reduces 30 day all cause mortality in high risk patients;Secondary Objective: Methylprednisolon given before cardiopulmonary bypass reduces 30 day all cause mortality in high risk patients or significant myocardial injury in these patients;Primary end point(s): allcouse mortality at 30 days;Timepoint(s) of evaluation of this end point: 30 days	—

Measure

Time frame

Main Objective: Methylprednisolon given before cardiopulmonary bypass reduces 30 day all cause mortality in high risk patients;Secondary Objective: Methylprednisolon given before cardiopulmonary bypass reduces 30 day all cause mortality in high risk patients or significant myocardial injury in these patients;Primary end point(s): allcouse mortality at 30 days;Timepoint(s) of evaluation of this end point: 30 days

—

Secondary

Measure	Time frame
Secondary end point(s): incidence of a composite of significant myocardial inury or death at 30 days;Timepoint(s) of evaluation of this end point: 30 days	—

Countries

Austria, Canada

Contacts

Public ContactRichard Whitlock

Population Health Research Institute

Outcome results

None listed

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