A French study on adult patients intubated for multiple trauma assessed the effect of a one week course of stress-dose hydrocortisone therapy against placebo on the incidence of hospital-acquired pneumonia. Multiple trauma was defined as having 2 or more traumatic injuries and an injury severity score higher than 15. The primary outcome measure was hospital-acquired pneumonia, defined by robust criteria and requiring positive lower respiratory tract microbiology. The study was not powered to detect a difference in mortality. The authors conclude that a stress dose of hydrocortisone for 7 days is associated with a reduction in the rate of hospital-acquired pneumonia at day 28 together with a decreased requirement for mechanical ventilation and length of ICU stay in trauma patients.
An accompanying editorial, highlighting the contrast in these results with those of other steroid-studies such as the CRASH trial, which used higher doses of steroid for a shorter period, cautions:
“the overall evidence suggests that further study with a larger sample size is needed to better define the safety profile and risk of mortality in this patient population.”
Context 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, Setting, and Patients Multicenter, randomized, double-blind, placebo-controlled HYPOLYTE (Hydrocortisone Polytraumatise) study. From November 2006 to August 2009, 150 patients with severe trauma were included in 7 intensive care units in France.
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.
Main Outcome Measure Hospital-acquired pneumonia within 28 days. Secondary outcomes included the duration of mechanical ventilation, hyponatremia, and death.
Results One patient withdrew consent. An intention-to-treat (ITT) analysis included the 149 patients, a 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 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).
Conclusion 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.
Hydrocortisone therapy for patients with multiple trauma: the randomized controlled HYPOLYTE study
JAMA. 2011 Mar 23;305(12):1201-9