Dexamethasone for Cardiac Surgery Trial

UMC Utrecht

Status: Completed

Conditions: Postoperative Complications; Cardiac Diseases; Systemic Inflammatory Response Syndrome

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00293592

DECS

Details and patient eligibility

About

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.

Enrollment: 4,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,500 participants in 2 patient groups, including a placebo group

Dexamethasone

Active Comparator group

Treatment:

Drug: Dexamethasone

Placebo

Placebo Comparator group

Treatment:

Drug: Dexamethasone