Clinical question: Does hydrocortisone therapy prevent progression to septic shock in patients with severe sepsis without shock?
Background: Current sepsis management guidelines recommend use of hydrocortisone in patients with septic shock who are unable to restore hemodynamic stability with IV fluids and pressors; current guidelines also recommend against use of corticosteroids without shock. However, these recommendations are based on two RCTs and remain controversial.
Study design: Multicenter, placebo-controlled, double-blind RCT.
Setting: Thirty-four intermediate or intensive care units in German university and community hospitals.
Synopsis: Investigators randomly assigned 380 patients to hydrocortisone or placebo. Patients were included if they had clinical evidence of infection, evidence of SIRS (systemic inflammatory response syndrome), and evidence of organ dysfunction. Patients were excluded if they had any of the following: sepsis-induced hypotension, separate indication for systemic steroid use, or hypersensitivity to steroids. Primary outcome was the occurrence of septic shock within 14 days. Secondary outcomes included time to septic shock or death, death in the ICU or hospital, organ dysfunction, ventilator therapy, renal replacement therapy, and secondary infection.
Study results showed no significant difference in the primary outcome between groups, or in any of the secondary outcomes. In a post-hoc analysis, there was more hyperglycemia and less delirium in the study group.
Study limitations are inclusion of patients only after consent, potentially missing early septic shock, and the fact that many analyses were done post-hoc.
Bottom line: Steroids should be avoided in severe sepsis without shock.
Citation: Keh D, Trips E, Marx G, et al. Effect of hydrocortisone on development of shock among patients with severe sepsis. JAMA. 2016;316(17):1775-85.
Dr. Graves is an assistant professor at the University of Utah School of Medicine and associate program director of quality and patient safety for the University of Utah Internal Medicine residency training program.
