ABSTRACT
BACKGROUND: High-dose corticosteroids have been used to attenuate the inflammatory response to cardiac surgery and cardiopulmonary bypass, but patient outcome benefits remain unclear. Our primary aim was to determine whether using dexamethasone was superior to not using dexamethasone to increase the number of home days in the first 30 days after cardiac surgery. Our secondary aim was to evaluate efficiency, value and impact of the novel trial design. METHODS: This pragmatic, international trial incorporating a prerandomized consent design favoring local practice enrolled patients undergoing cardiac surgery across 7 hospitals in Australia and The Netherlands. Patients were randomly assigned to dexamethasone, 1 mg/kg, or not (control). The primary outcome was the number of days alive and at home up to 30 days after surgery ("home days"). Secondary outcomes included prolonged mechanical ventilation (>48 h), sepsis, renal failure, myocardial infarction, stroke and death. RESULTS: Of 2093 patients assessed for eligibility, 1951 were randomized (median age 63 years, 80% male). The median number of home days was 23.0 (IQR, 20.1 to 24.1) in the dexamethasone group and 23.1 (IQR, 20.1 to 24.6) in the no dexamethasone group; median difference 0.1 (95% CI, -0.3 to 0.5), P=0.66. The rates of prolonged mechanical ventilation, RR 0.72 (95% CI, 0.48 to 1.08), sepsis, RR 1.02 (95% CI, 0.57 to 1.82), renal failure, RR 0.94 (95% CI, 0.80 to 1.12), myocardial infarction, RR 1.20 (95% CI, 0.30 to 4.82), stroke, RR 1.06 (95% CI, 0.54 to 2.08), and death, RR 0.72 (95% CI, 0.22 to 2.35), were comparable between groups (all P>0.10). Dexamethasone reduced intensive care unit stay, median 29 (IQR, 22 to 50) h vs. 43 (24 to 72) h, P=0.004. Our novel trial design was highly efficient (89.3% enrolment). CONCLUSIONS: Among patients undergoing cardiac surgery, high-dose dexamethasone decreased intensive care unit stay but did not increase the number of home days after surgery.
ABSTRACT
PURPOSE: Investigation of adverse events associated with anesthetic procedures is a method of quality control that identifies topics to improve clinical care and patient safety. Most research to date has been based on closed claim registries and anonymous reports which have specific limitations. Therefore, to evaluate a hospital's reporting system, the present study was designed to describe critical incidents that anesthesiologists voluntarily and non-anonymously reported through an anesthesia information management system. METHODS: This is a historical observational cohort study on patients (age > 18 yr) undergoing anesthetic procedures in a tertiary referral hospital. A 20-item list of complications, as developed by the Netherlands Society of Anesthesiologists, was prospectively completed for each procedure. All critical incidents registered in the anesthesia information management system were then reclassified into 95 different critical incidents in a reproducible way. RESULTS: There were 110,310 procedures performed in 65,985 patients, and after excluding 158 reports that did not depict a critical incident, 3,904 critical incidents in 3,807 (3.5%) anesthetic procedures remained. Technical difficulties with regional anesthesia (n = 445; 40 per 10,000 anesthetics; 95% confidence interval [CI], 36 to 44), hypotension (n = 432; 39 per 10,000 anesthetics; 95% CI, 35 to 43), and unexpected difficult intubation (n = 216; 20 per 10,000 anesthetics; 95% CI, 18 to 23) were the most frequently documented critical incidents. CONCLUSION: Accurate measurement and monitoring of critical incidents is crucial for patient safety. Despite the risk of underreporting and probable misclassification of manual reporting systems, our results give a comprehensive overview on the occurrence of voluntarily reported anesthesia-related critical incidents. This overview can direct development of a new reporting system and preventive strategies to decrease the future occurrence of critical incidents.
