Glucocorticoid therapy for trauma - ready for prime time?

Abstract

BACKGROUND:The role of stress-dose hydrocortisone in the management of trauma patients is currently unknown.OBJECTIVE:To test the efficacy of hydrocortisone therapy in trauma patients.DESIGN:Multicenter randomized, double blind, placebo-controlled study. Setting: Seven ICU's in France during November 2006 to August 2009. Subjects: 150 patients with severe trauma who required ICU stay for at least 48 hours were included in the study. Intervention: Patients were randomly assigned to a continuous intravenous infusion of either hydrocortisone (200 mg/d for 5 days, followed by 100 mg on day 6 and 50 mg on day 7) or placebo. The treatment was stopped if patients had an appropriate adrenal response. Outcomes: Hospital-acquired pneumonia within 28 days. Secondary outcomes included the duration of mechanical ventilation, ICU length of stay, hyponatremia, and death.RESULTS:An intention-to-treat (ITT) analysis included 149 patients and the modified ITT analysis included 113 patients with corticosteroid insufficiency. In the ITT analysis, 26 of 73 patients (35.6%) treated with hydrocortisone and 39 of 76 patients (51.3%) receiving placebo developed hospital-acquired pneumonia by day 28 (hazard ratio [HR], 0.51; 95% confidence interval [CI], 0.30-0.83; P = .007). In the modified ITT analysis, 20 of 56 patients (35.7%) in the hydrocortisone group and 31 of 57 patients (54.4%) in the placebo group developed hospital-acquired pneumonia by day 28 (HR, 0.47; 95% CI, 0.25-0.86; P = .01). Mechanical ventilation-free days increased with hydrocortisone use by 4 days (95% CI, 2-7; P = .001) in the ITT analysis and 6 days (95% CI, 2-11; P < .001) in the modified ITT analysis. Hyponatremia was observed in 7 of 76 (9.2%) in the placebo group vs. none in the hydrocortisone group (absolute difference, 9%; 95% CI, 16% to 3%; P = .01). Four of 76 patients (5.3%) in the placebo group and 6 of 73 (8.2%) in the hydrocortisone group died (absolute difference, 3%; 95% CI, 5% to 11%; P = .44).CONCLUSIONS:In intubated trauma patients, the use of an intravenous stress-dose of hydrocortisone, compared with placebo, resulted in a decreased risk of hospital-acquired pneumonia.