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Dexamethasone for Cardiac Surgery Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00293592
First Posted: February 17, 2006
Last Update Posted: April 21, 2015
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.
Information provided by (Responsible Party):
D van Dijk, UMC Utrecht
  Purpose
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.

Condition Intervention
Systemic Inflammatory Response Syndrome Cardiac Diseases Postoperative Complications Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone for Cardiac Surgery Trial

Resource links provided by NLM:


Further study details as provided by D van Dijk, UMC Utrecht:

Primary Outcome Measures:
  • Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) [ Time Frame: 30 days postoperatively ]

Enrollment: 4500
Study Start Date: May 2006
Study Completion Date: December 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexamethasone Drug: Dexamethasone
1 mg per kg as a single dose before initiation of cardiopulmonary bypass
Placebo Comparator: Placebo Drug: Dexamethasone
1 mg per kg as a single dose before initiation of cardiopulmonary bypass

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293592


Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
UMC Utrecht
Investigators
Study Chair: CJ Kalkman, MD, PhD UMC Utrecht
Study Director: D van Dijk, MD, PhD UMC Utrecht
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: D van Dijk, Anesthesiologist/Intensivist, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00293592     History of Changes
Other Study ID Numbers: DECS
First Submitted: February 16, 2006
First Posted: February 17, 2006
Last Update Posted: April 21, 2015
Last Verified: April 2015

Keywords provided by D van Dijk, UMC Utrecht:
Heart surgery
Cardiopulmonary bypass
Systemic Inflammatory Response Syndrome (SIRS)

Additional relevant MeSH terms:
Postoperative Complications
Heart Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes
Cardiovascular Diseases
Inflammation
Shock
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action