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Dexamethasone for Cardiac Surgery Trial

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ClinicalTrials.gov Identifier: NCT00293592
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : April 21, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Systemic Inflammatory Response Syndrome Cardiac Diseases Postoperative Complications Drug: Dexamethasone

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone for Cardiac Surgery Trial
Study Start Date : May 2006
Primary Completion Date : November 2011
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Dexamethasone Drug: Dexamethasone
1 mg per kg as a single dose before initiation of cardiopulmonary bypass
Placebo Comparator: Placebo Drug: Dexamethasone
1 mg per kg as a single dose before initiation of cardiopulmonary bypass

Outcome Measures

Primary Outcome Measures :
  1. Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) [ Time Frame: 30 days postoperatively ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293592

UMC Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
UMC Utrecht
Study Chair: CJ Kalkman, MD, PhD UMC Utrecht
Study Director: D van Dijk, MD, PhD UMC Utrecht
More Information


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: D van Dijk, Anesthesiologist/Intensivist, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00293592     History of Changes
Other Study ID Numbers: DECS
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by D van Dijk, UMC Utrecht:
Heart surgery
Cardiopulmonary bypass
Systemic Inflammatory Response Syndrome (SIRS)

Additional relevant MeSH terms:
Postoperative Complications
Heart Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes
Cardiovascular Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action