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 1, 2014
Last verified: April 2014
  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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 1, 2014
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
Syndrome
Systemic Inflammatory Response Syndrome
Cardiovascular Diseases
Disease
Inflammation
Pathologic Processes
Shock
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014