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Dexamethasone for Cardiac Surgery Trial

NCT00293592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4500

Last updated 2015-04-21

No results posted yet for this study

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.

Conditions

  • Systemic Inflammatory Response Syndrome
  • Cardiac Diseases
  • Postoperative Complications

Interventions

DRUG

Dexamethasone

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

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • CJ Kalkman, MD, PhD · UMC Utrecht

  • D van Dijk, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2011-11-30
Completion
2012-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00293592 on ClinicalTrials.gov