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Dexamethasone for Cardiac Surgery Trial

Primary Purpose

Systemic Inflammatory Response Syndrome, Cardiac Diseases, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Inflammatory Response Syndrome focused on measuring Heart surgery, Cardiopulmonary bypass, Systemic Inflammatory Response Syndrome (SIRS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h)

Secondary Outcome Measures

Full Information

First Posted
February 16, 2006
Last Updated
April 18, 2015
Sponsor
UMC Utrecht
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1. Study Identification

Unique Protocol Identification Number
NCT00293592
Brief Title
Dexamethasone for Cardiac Surgery Trial
Official Title
Dexamethasone for Cardiac Surgery Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Inflammatory Response Syndrome, Cardiac Diseases, Postoperative Complications
Keywords
Heart surgery, Cardiopulmonary bypass, Systemic Inflammatory Response Syndrome (SIRS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
1 mg per kg as a single dose before initiation of cardiopulmonary bypass
Primary Outcome Measure Information:
Title
Composite endpoint of mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation (> 48h)
Time Frame
30 days postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CJ Kalkman, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
D van Dijk, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Study Director
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25817849
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 2014 Dec 3.
Results Reference
result
PubMed Identifier
25596472
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 fibrillation. Int J Cardiol. 2015 Mar 1;182:431-7. doi: 10.1016/j.ijcard.2014.12.094. Epub 2015 Jan 8.
Results Reference
result
PubMed Identifier
25475514
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):168-73. doi: 10.1007/s12471-014-0638-5.
Results Reference
result
PubMed Identifier
25225745
Citation
Ottens TH, Dieleman JM, Sauer 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 clinical trial. Anesthesiology. 2014 Sep;121(3):492-500. doi: 10.1097/ALN.0000000000000336.
Results Reference
result
PubMed Identifier
24952869
Citation
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. 2014 Jul;168(1):126-31.e1. doi: 10.1016/j.ahj.2014.03.017. Epub 2014 Apr 5.
Results Reference
result
PubMed Identifier
24810262
Citation
Sauer 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.
Results Reference
result
PubMed Identifier
23117776
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 dexamethasone for cardiac surgery: a randomized controlled trial. JAMA. 2012 Nov 7;308(17):1761-7. doi: 10.1001/jama.2012.14144.
Results Reference
result
PubMed Identifier
28854542
Citation
Sauer AC, Veldhuijzen DS, Ottens TH, Slooter AJC, Kalkman CJ, van Dijk D. Association between delirium and cognitive change after cardiac surgery. Br J Anaesth. 2017 Aug 1;119(2):308-315. doi: 10.1093/bja/aex053.
Results Reference
derived
PubMed Identifier
25952257
Citation
Jacob KA, Leaf DE, Dieleman JM, van Dijk D, Nierich AP, Rosseel PM, van der Maaten JM, Hofland J, Diephuis JC, de Lange F, Boer C, Kluin J, Waikar SS; Dexamethasone for Cardiac Surgery (DECS) Study Group. Intraoperative High-Dose Dexamethasone and Severe AKI after Cardiac Surgery. J Am Soc Nephrol. 2015 Dec;26(12):2947-51. doi: 10.1681/ASN.2014080840. Epub 2015 May 7.
Results Reference
derived
PubMed Identifier
25886901
Citation
Ottens TH, Nijsten MW, Hofland J, Dieleman JM, Hoekstra M, van Dijk D, van der Maaten JM. Effect of high-dose dexamethasone on perioperative lactate levels and glucose control: a randomized controlled trial. Crit Care. 2015 Feb 13;19(1):41. doi: 10.1186/s13054-015-0736-9.
Results Reference
derived

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Dexamethasone for Cardiac Surgery Trial

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