Cardiac Diseases, Postoperative Complications, Systemic Inflammatory Response Syndrome
Conditions
Keywords
Heart surgery, Cardiopulmonary bypass, Systemic Inflammatory Response Syndrome (SIRS)
Brief summary
This is a multicenter, randomized, double-blind trial, comparing clinical outcomes after the administration of high-dose dexamethasone versus placebo in patients undergoing heart surgery with the use of cardiopulmonary bypass. The primary endpoint is the occurrence of major complications (including all-cause mortality, myocardial infarction, stroke, renal failure, and prolonged mechanical ventilation) in the first 30 days after surgery.
Interventions
DRUGDexamethasone
1 mg per kg as a single dose before initiation of cardiopulmonary bypass
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All types of cardiac surgery in which cardiopulmonary bypass is used
Exclusion criteria
* Age under 18 years * Life-expectancy \< 6 months * Emergency operations * Re-operations within the same admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) | 30 days postoperatively |
Countries
Netherlands
Outcome results
None listed