Dexamethasone for Cardiac Surgery Trial

Not Applicable

Completed

• Conditions: Systemic Inflammatory Response Syndrome; Cardiac Diseases; Postoperative Complications
• Interventions: Drug: Dexamethasone

• Registration Number: NCT00293592
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-16
• Study First Submitted QC: 2006-02-16
• Study First Posted: 2006-02-17
• Study Start: 2006-05
• Primary Completion: 2011-11
• Study Completion: 2012-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-18
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	-
Placebo	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h)	30 days postoperatively

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands