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NCT00293592 Clinical Trial

Dexamethasone for Cardiac Surgery Trial

Postoperative Complications Clinical Trial

Official title:
Dexamethasone for Cardiac Surgery Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00293592
Other study ID # DECS
Secondary ID
Status Completed
Phase N/A
First received February 16, 2006
Last updated April 18, 2015
Start date May 2006
Est. completion date December 2012

Study information
Verified date April 2015
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4500
Est. completion date December 2012
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone
1 mg per kg as a single dose before initiation of cardiopulmonary bypass

Locations
Country Name City State
Netherlands UMC Utrecht Utrecht

Sponsors (1)
Lead Sponsor Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

Bunge JJ, van Osch D, Dieleman JM, Jacob KA, Kluin J, van Dijk D, Nathoe HM; Dexamethasone for Cardiac Surgery (DECS) Study Group. Dexamethasone for the prevention of postpericardiotomy syndrome: A DExamethasone for Cardiac Surgery substudy. Am Heart J. 2 — View Citation

Dieleman JM, Nierich AP, Rosseel PM, van der Maaten JM, Hofland J, Diephuis JC, Schepp RM, Boer C, Moons KG, van Herwerden LA, Tijssen JG, Numan SC, Kalkman CJ, van Dijk D; Dexamethasone for Cardiac Surgery (DECS) Study Group. Intraoperative high-dose dex — View Citation

Jacob KA, Dieleman JM, Nathoe HM, van Osch D, de Waal EE, Cramer MJ, Kluin J, van Dijk D. The effects of intraoperative dexamethasone on left atrial function and postoperative atrial fibrillation in cardiac surgical patients. Neth Heart J. 2015 Mar;23(3): — View Citation

Ottens TH, Dieleman JM, Sauër AM, Peelen LM, Nierich AP, de Groot WJ, Nathoe HM, Buijsrogge MP, Kalkman CJ, van Dijk D; DExamethasone for Cardiac Surgery (DECS) Study Group. Effects of dexamethasone on cognitive decline after cardiac surgery: a randomized — View Citation

Ottens TH, Hendrikse J, Slooter AJ, van Herwerden LA, Dieleman JM, van Dijk D. Low incidence of early postoperative cerebral edema after coronary artery bypass grafting. J Cardiothorac Vasc Anesth. 2015;29(3):632-6. doi: 10.1053/j.jvca.2014.12.004. Epub 2 — View Citation

Sauër AM, Slooter AJ, Veldhuijzen DS, van Eijk MM, Devlin JW, van Dijk D. Intraoperative dexamethasone and delirium after cardiac surgery: a randomized clinical trial. Anesth Analg. 2014 Nov;119(5):1046-52. doi: 10.1213/ANE.0000000000000248. — View Citation

van Osch D, Dieleman JM, van Dijk D, Jacob KA, Kluin J, Doevendans PA, Nathoe HM; DExamethasone for Cardiac Surgery (DECS) study group; DExamethasone for Cardiac Surgery DECS study group. Dexamethasone for the prevention of postoperative atrial fibrillati — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h) 30 days postoperatively No
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