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Dexamethasone for Cardiac Surgery Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
D van Dijk, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00293592
First received: February 16, 2006
Last updated: February 3, 2012
Last verified: February 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone for Cardiac Surgery Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) [ Time Frame: 30 days postoperatively ] [ Designated as safety issue: No ]

Enrollment: 4500
Study Start Date: May 2006
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by UMC Utrecht

Additional 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
Study First Received: February 16, 2006
Last Updated: February 3, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Heart Diseases
Postoperative Complications
Systemic Inflammatory Response Syndrome
Cardiovascular Diseases
Pathologic Processes
Inflammation
Shock
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013