6/28/23, 12:17 AM CORTICUS Pathway Feedback Search Clinical Topics Home Studies CORTICUS CORTICUS Disease Sepsis and septic shock Trial question What is the role of hydrocortisone therapy in patients with septic shock? Study design Multi-center Double blinded RCT Population Characteristics of study participants 33.0% female N = 499 67.0% male 499 patients (167 female, 332 male) Inclusion criteria: patients with septic shock Key exclusion criteria: underlying disease with a poor prognosis, a life expectancy of < 24 hours, immunosuppression, and treatment with long-term corticosteroids within the past 6 months or short-term corticosteroids within the past 4 weeks Interventions N=251 hydrocortisone (intravenous 50 mg every 6 hours for 5 days) N=248 placebo (identical placebo intravenous every 6 hours for 5 days) Primary outcome Death at 28 days, among corticotropin non-responders 39.2 % 39.2 36.1 29.4 % https://web.pathway.md/studies/recTNWh0easoznNaB 1/2 6/28/23, 12:17 AM CORTICUS Pathway 19.6 % 9.8 % No significant difference 0.0 % Hydrocortisone Placebo No significant difference in death at 28 days, among corticotropin non-responders (39.2% vs. 36.1%; RR 1.09, 95% CI 0.77 to 1.52) Secondary outcomes No significant difference in death at 28 days, among corticotropin responders (28.8% vs. 28.7%; RR 1, 95% CI 0.68 to 1.49) No significant difference in death at 28 days (34.3% vs. 31.5%; RR 1.09, 95% CI 0.84 to 1.41) Significant decrease in time to reversal of shock (3.3 days vs. 5.8 days; AD -2.5 days, 95% CI -3.98 to -1.02) Safety outcomes Significant differences in new sepsis (3% vs. 1%), new shock (6% vs. 2%), new hyperglycemia (85% vs. 72%), and new hypernatremia (29% vs. 18%). Conclusion In patients with septic shock, hydrocortisone was not superior to placebo with respect to death at 28 days, among corticotropin non-responders. Reference Sprung CL, Annane D, Keh D et al. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008 Jan 10;358(2):111-24. Open reference URL https://web.pathway.md/studies/recTNWh0easoznNaB 2/2