Dexamethasone for Cardiac Surgery Trial

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.

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Key information

Conditions

Systemic Inflammatory Response Syndrome Cardiac Diseases Cardiovascular Diseases Heart Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Utrecht

Utrecht, 3584CX, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

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

Primary outcomes

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

Time frame: 30 days postoperatively

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2012
First posted: Feb 17, 2006
Registry last updated: Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed