Dexamethasone for Cardiac Surgery Trial
This study has been completed.
Sponsor:
UMC Utrecht
Information provided by (Responsible Party):
D van Dijk, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00293592
First received: February 16, 2006
Last updated: April 1, 2014
Last verified: April 2014
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 16, 2006 | ||||||||
| Last Updated Date | April 1, 2014 | ||||||||
| Start Date ICMJE | May 2006 | ||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00293592 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Dexamethasone for Cardiac Surgery Trial | ||||||||
| Official Title ICMJE | Dexamethasone for Cardiac Surgery Trial | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Dexamethasone
1 mg per kg as a single dose before initiation of cardiopulmonary bypass |
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| Study Arm (s) |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 4500 | ||||||||
| Completion Date | December 2012 | ||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Listed Location Countries ICMJE | Netherlands | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00293592 | ||||||||
| Other Study ID Numbers ICMJE | DECS | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | D van Dijk, UMC Utrecht | ||||||||
| Study Sponsor ICMJE | UMC Utrecht | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | UMC Utrecht | ||||||||
| Verification Date | April 2014 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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