Dexamethasone for Cardiac Surgery Trial
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00293592 |
Recruitment Status
:
Completed
First Posted
: February 17, 2006
Last Update Posted
: April 21, 2015
|
Sponsor:
UMC Utrecht
Information provided by (Responsible Party):
D van Dijk, UMC Utrecht
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | February 16, 2006 | ||||||
First Posted Date ICMJE | February 17, 2006 | ||||||
Last Update Posted Date | April 21, 2015 | ||||||
Study Start Date ICMJE | May 2006 | ||||||
Actual 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 ] | ||||||
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 Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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 Arms |
|
||||||
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 | ||||||
Actual Enrollment ICMJE |
4500 | ||||||
Original Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date | December 2012 | ||||||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender |
|
||||||
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 | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | D van Dijk, UMC Utrecht | ||||||
Study Sponsor ICMJE | UMC Utrecht | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
|
||||||
PRS Account | UMC Utrecht | ||||||
Verification Date | April 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |