title: Intraoperative high-dose dexamethasone for cardiac surgery: a randomized controlled trial.
abstract: BACKGROUND
  Prophylactic corticosteroids are often administered during cardiac surgery to attenuate the inflammatory response to cardiopulmonary bypass and surgical trauma; however, evidence that routine corticosteroid use can prevent major adverse events is lacking.
  
  
  OBJECTIVE
  To quantify the effect of intraoperative high-dose dexamethasone on the incidence of major adverse events in patients undergoing cardiac surgery.
  
  
  METHODS
  A multicenter, randomized, double-blind, placebo-controlled trial of 4494 patients aged 18 years or older undergoing cardiac surgery with cardiopulmonary bypass at 8 cardiac surgical centers in The Netherlands enrolled between April 13, 2006, and November 23, 2011.
  
  
  METHODS
  Patients were randomly assigned to receive a single intraoperative dose of 1 mg/kg dexamethasone (n = 2239) or placebo (n = 2255).
  
  
  METHODS
  A composite of death, myocardial infarction, stroke, renal failure, or respiratory failure, within 30 days of randomization.
  
  
  RESULTS
  Of the 4494 patients who underwent randomization, 4482 (99.7%) could be evaluated for the primary outcome. A total of 157 patients (7.0%) in the dexamethasone group and 191 patients (8.5%) in the placebo group reached the primary study end point (relative risk, 0.83; 95% CI, 0.67-1.01; absolute risk reduction, -1.5%; 95% CI, -3.0% to 0.1%; P = .07). Dexamethasone was associated with reductions in postoperative infection, duration of postoperative mechanical ventilation, and lengths of intensive care unit and hospital stays. In contrast, dexamethasone was associated with higher postoperative glucose levels.
  
  
  CONCLUSIONS
  In our trial of adults undergoing cardiac surgery, the use of intraoperative dexamethasone did not reduce the 30-day incidence of major adverse events compared with placebo.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00293592.
authors.affiliation: Division of Anesthesiology, Intensive Care, and Emergency Medicine, University Medical Center Utrecht, PO Box 85500, 3508 GA, Utrecht, The Netherlands. s.dieleman@umcutrecht.nl.
authors.forename: Jan M
authors.initials: JM
authors.lastname: Dieleman
authors.forename: Arno P
authors.initials: AP
authors.lastname: Nierich
authors.forename: Peter M
authors.initials: PM
authors.lastname: Rosseel
authors.forename: Joost M
authors.initials: JM
authors.lastname: van der Maaten
authors.forename: Jan
authors.initials: J
authors.lastname: Hofland
authors.forename: Jan C
authors.initials: JC
authors.lastname: Diephuis
authors.forename: Ronald M
authors.initials: RM
authors.lastname: Schepp
authors.forename: Christa
authors.initials: C
authors.lastname: Boer
authors.forename: Karel G
authors.initials: KG
authors.lastname: Moons
authors.forename: Lex A
authors.initials: LA
authors.lastname: van Herwerden
authors.forename: Jan G
authors.initials: JG
authors.lastname: Tijssen
authors.forename: Sandra C
authors.initials: SC
authors.lastname: Numan
authors.forename: Cor J
authors.initials: CJ
authors.lastname: Kalkman
authors.forename: Diederik
authors.initials: D
authors.lastname: van Dijk
mesh_terms: D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D006348:Cardiac Surgical Procedures; D002315:Cardiopulmonary Bypass; D003907:Dexamethasone / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007249:Inflammation / Q000150:complications / Q000209:etiology / Q000517:prevention & control; D007432:Intraoperative Period; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control; D011183:Postoperative Complications / Q000517:prevention & control*; D051437:Renal Insufficiency / Q000517:prevention & control; D012131:Respiratory Insufficiency / Q000517:prevention & control; D020521:Stroke / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D003907:Dexamethasone