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Effect of Hydrocortisone on Development of Shock among Patients with Severe Sepsis
Effect of Hydrocortisone on Development of Shock among Patients with Severe Sepsis
Keh D, Trips E, Marx G, et al. JAMA 2016; 316: 1775-1785.
Study Question: In patients with severe sepsis, does the use of hydrocortisone decrease the occurrence of septic shock within 14 days?
Study Description: This multicenter, randomized, double-blind, placebo-controlled trial enrolled patients with severe sepsis, defined by the 2012 Surviving Sepsis Campaign Guidelines. Exclusion criteria were septic shock, severe sepsis ≥48 hours and other indications for steroid therapy. Patients received an IV bolus of 50 mg of hydrocortisone then a continuous infusion of 200 mg daily for 5 days followed by a taper over the next 6 days, or matching placebo. The primary endpoint was progression to septic shock within 14 days. Secondary endpoints included time to septic shock onset or death, time with septic shock, 28-, 90- and 180-day mortality, ICU LOS, and organ dysfunction.
Results: A total of 380 patients were included, of which septic shock developed in 21.2% of the hydrocortisone group vs. 22.9% in the placebo group (95% CI -10.7% to 7.2%, p = 0.70). No differences were seen with any of the secondary endpoints. Adverse event analysis found more episodes of hyperglycemia in the hydrocortisone group compared to placebo, yet lower incidence of delirium.
Conclusion: Administration of hydrocortisone to patients with severe sepsis did not reduce the occurrence of septic shock.
Perspective: Despite recent findings suggesting a positive effect of steroids on outcomes, including progression to shock for severe CAP, this study was unable to identify a benefit of steroids for the prevention of shock in high risk patients. At this time, consideration of steroid therapy for sepsis should be reserved for those patients with shock.