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 18, 2015
Last verified: April 2015
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | February 16, 2006 | ||||||
| Last Updated Date | April 18, 2015 | ||||||
| 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. | ||||||
| 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 |
||||||
| Condition ICMJE |
|
||||||
| Intervention ICMJE | Drug: Dexamethasone
1 mg per kg as a single dose before initiation of cardiopulmonary bypass |
||||||
| Study Arm (s) |
|
||||||
| Publications * |
|
||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| 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:
|
||||||
| Gender | Both | ||||||
| Ages | 18 Years and older (Adult, Senior) | ||||||
| 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 | ||||||
| Plan to Share Data | Not Provided | ||||||
| IPD Description | Not Provided | ||||||
| Responsible Party | D van Dijk, UMC Utrecht | ||||||
| Study Sponsor ICMJE | UMC Utrecht | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
|
||||||
| Information Provided By | UMC Utrecht | ||||||
| Verification Date | April 2015 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||