Dexamethasone for Cardiac Surgery Trial

UMC Utrecht4,500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

4,500

Conditions

Systemic Inflammatory Response Syndrome Cardiac Diseases Postoperative Complications

Interventions

DexamethasoneDRUG

1 mg per kg as a single dose before initiation of cardiopulmonary bypass

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UMC Utrecht

Utrecht, Netherlands

Outcomes

Primary Outcomes

Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h)

Time frame: 30 days postoperatively

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.