Dexamethasone for Cardiac Surgery Trial

NCT ID: NCT00293592

Last Updated: 2015-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Inflammatory Response Syndrome Cardiac Diseases Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

1 mg per kg as a single dose before initiation of cardiopulmonary bypass

Placebo

Group Type PLACEBO_COMPARATOR

Dexamethasone

Intervention Type DRUG

1 mg per kg as a single dose before initiation of cardiopulmonary bypass

Interventions

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Dexamethasone

1 mg per kg as a single dose before initiation of cardiopulmonary bypass

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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D van Dijk

Anesthesiologist/Intensivist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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CJ Kalkman, MD, PhD

Role: STUDY_CHAIR

UMC Utrecht

D van Dijk, MD, PhD

Role: STUDY_DIRECTOR

UMC Utrecht

Locations

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UMC Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT
PMID: 25817849 (View on PubMed)

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.

Reference Type RESULT
PMID: 25596472 (View on PubMed)

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.

Reference Type RESULT
PMID: 25475514 (View on PubMed)

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.

Reference Type RESULT
PMID: 25225745 (View on PubMed)

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.

Reference Type RESULT
PMID: 24952869 (View on PubMed)

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.

Reference Type RESULT
PMID: 24810262 (View on PubMed)

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.

Reference Type RESULT
PMID: 23117776 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28854542 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25952257 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25886901 (View on PubMed)

Other Identifiers

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DECS

Identifier Type: -

Identifier Source: org_study_id

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