Dexamethasone for Cardiac Surgery Trial

This study has been completed.

Sponsor:

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

History of Changes

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 ]

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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Systemic Inflammatory Response Syndrome
Cardiac Diseases
Postoperative Complications

Intervention ^ICMJE

Drug: Dexamethasone

1 mg per kg as a single dose before initiation of cardiopulmonary bypass

Study Arms

Active Comparator: Dexamethasone
Intervention: Drug: Dexamethasone
Placebo Comparator: Placebo
Intervention: Drug: Dexamethasone

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:

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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

Study Chair:	CJ Kalkman, MD, PhD	UMC Utrecht
Study Director:	D van Dijk, MD, PhD	UMC Utrecht

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

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