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Dexamethasone for Cardiac Surgery Trial

This study has been completed.
Information provided by (Responsible Party):
D van Dijk, UMC Utrecht Identifier:
First received: February 16, 2006
Last updated: April 18, 2015
Last verified: April 2015
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 Intervention
Systemic Inflammatory Response Syndrome Cardiac Diseases Postoperative Complications Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone for Cardiac Surgery Trial

Resource links provided by NLM:

Further study details as provided by D van Dijk, UMC Utrecht:

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

Enrollment: 4500
Study Start Date: May 2006
Study Completion Date: December 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
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Please refer to this study by its identifier: 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 Identifier (NCT Number):
Responsible Party: D van Dijk, Anesthesiologist/Intensivist, UMC Utrecht Identifier: NCT00293592     History of Changes
Other Study ID Numbers: DECS
Study First Received: February 16, 2006
Last Updated: April 18, 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 processed this record on September 21, 2017