Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 1, 2014
Last verified: April 2014

February 16, 2006
April 1, 2014
May 2006
November 2011   (final data collection date for primary outcome measure)
Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00293592 on Archive Site
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Dexamethasone for Cardiac Surgery Trial
Dexamethasone for Cardiac Surgery Trial

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.

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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Systemic Inflammatory Response Syndrome
  • Cardiac Diseases
  • Postoperative Complications
Drug: Dexamethasone
1 mg per kg as a single dose before initiation of cardiopulmonary bypass
  • Active Comparator: Dexamethasone
    Intervention: Drug: Dexamethasone
  • Placebo Comparator: Placebo
    Intervention: Drug: Dexamethasone
Dieleman JM, Nierich AP, Rosseel PM, van der Maaten JM, Hofland J, Diephuis JC, Schepp RM, Boer C, Moons KG, van Herwerden LA, Tijssen JG, Numan SC, Kalkman CJ, van Dijk D; Dexamethasone for Cardiac Surgery (DECS) Study Group. Intraoperative high-dose dexamethasone for cardiac surgery: a randomized controlled trial. JAMA. 2012 Nov 7;308(17):1761-7. doi: 10.1001/jama.2012.14144.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
November 2011   (final data collection date for primary outcome measure)

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
D van Dijk, UMC Utrecht
UMC Utrecht
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Study Chair: CJ Kalkman, MD, PhD UMC Utrecht
Study Director: D van Dijk, MD, PhD UMC Utrecht
UMC Utrecht
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP