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| Sponsored by: |
UMC Utrecht |
|---|---|
| Information provided by: | UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00293592 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Systemic Inflammatory Response Syndrome Cardiac Diseases Postoperative Complications |
Drug: Dexamethasone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Dexamethasone for Cardiac Surgery Trial |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: JM Dieleman, MD | S.Dieleman@UMCUtrecht.nl |
| Netherlands | |
| UMC Utrecht | Recruiting |
| Utrecht, Netherlands, 3584CX | |
| Contact: JM Dieleman, MD +31302509111 ext #3976 S.Dieleman@UMCUtrecht.nl | |
| Study Chair: | CJ Kalkman, MD, PhD | UMC Utrecht |
| Study Director: | D van Dijk, MD, PhD | UMC Utrecht |
More Information
| Study ID Numbers: | DECS |
| Study First Received: | February 16, 2006 |
| Last Updated: | April 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00293592 History of Changes |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
|
Heart surgery Cardiopulmonary bypass Systemic Inflammatory Response Syndrome (SIRS) |
|
Anti-Inflammatory Agents Systemic Inflammatory Response Syndrome Dexamethasone Heart Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Glucocorticoids Hormones Inflammation Postoperative Complications Shock Peripheral Nervous System Agents Dexamethasone acetate |
|
Dexamethasone Anti-Inflammatory Agents Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Pathologic Processes Syndrome Therapeutic Uses Cardiovascular Diseases Dexamethasone acetate Systemic Inflammatory Response Syndrome |
Disease Heart Diseases Antineoplastic Agents, Hormonal Gastrointestinal Agents Glucocorticoids Pharmacologic Actions Inflammation Shock Postoperative Complications Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |
