CClinicalTrials.gg
Sign In
CompletedNCT00293592Updated Apr 21, 2015

Dexamethasone for Cardiac Surgery Trial

An interventional study of Dexamethasone in Systemic Inflammatory Response Syndrome, Cardiac Diseases and Postoperative Complications, sponsored by UMC Utrecht. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-21.

Sponsored by UMC Utrecht · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4,500
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Systemic Inflammatory Response Syndrome
  • Cardiac Diseases
  • Postoperative Complications

Keywords

  • Heart surgery
  • Cardiopulmonary bypass
  • Systemic Inflammatory Response Syndrome (SIRS)
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 4,500 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All types of cardiac surgery in which cardiopulmonary bypass is used

Exclusion criteria

Exclusion Criteria:

  • Age under 18 years
  • Life-expectancy \< 6 months
  • Emergency operations
  • Re-operations within the same admission
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
4,500 participants (actual)

Study arms

  • Active comparator
    Dexamethasone

    Drug: Dexamethasone

  • Placebo comparator
    Placebo

    Drug: Dexamethasone

Interventions

  • DrugDexamethasone

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

06

What researchers measure

Primary outcomes

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

    Time frame: 30 days postoperatively

07

Study locations

1 site
  • UMC Utrecht
    Utrecht, 3584CX, Netherlands
08

References and documents

Publications

  • 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. PubMed 25817849 ↗
  • 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. PubMed 25596472 ↗
  • 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. PubMed 25475514 ↗
  • 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. PubMed 25225745 ↗
  • 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. PubMed 24952869 ↗
  • 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. PubMed 24810262 ↗
  • 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. PubMed 23117776 ↗
  • 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. PubMed 28854542 ↗
  • 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. PubMed 25952257 ↗
  • 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. PubMed 25886901 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00293592
Lead sponsor
UMC Utrecht
Responsible party
D van Dijk (Anesthesiologist/Intensivist, UMC Utrecht) — Principal investigator
First posted
Feb 17, 2006
Start date
May 2006
Primary completion
Nov 2011
Completion
Dec 2012
Last update
Apr 21, 2015

Study contacts

CJ Kalkman, MD, PhD
study chair · UMC Utrecht
D van Dijk, MD, PhD
study director · UMC Utrecht

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Heart Diseases→

Other studies from this sponsor

UMC Utrecht

Start the discussion