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Dexamethasone for Cardiac Surgery Trial
NCT00293592Phase 3
Key facts
- Status
- Completed
- Start
- May 2006
- Primary completion
- Nov 2011
- Countries
- 1
- Modality
- Orthosteric Ligands
- Drugs
- dexamethasone
- Conditions
- Systemic Inflammatory Response Syndrome (SIRS)postoperative complications
01
Overview
Phase 3, randomised, double-blind trial in Systemic Inflammatory Response Syndrome (SIRS) and postoperative complications comparing Dexamethasone with Placebo (2 arms). Primary endpoint: Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation at 30 days. Started May 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dexamethasone
Dexamethasone 1 mg/kg single dose
Placebo
Placebo single dose
03
Who it enrols
Adult patients undergoing cardiac surgery with cardiopulmonary bypass, excluding those with life expectancy < 6 months, emergency operations, or re-operations.
04
Endpoints
Primary
Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation
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