6/28/23, 12:03 AM ADRENAL Pathway Feedback Search Clinical Topics Home Studies ADRENAL ADRENAL Disease Sepsis and septic shock Trial question What is the role of hydrocortisone in patients with septic shock undergoing mechanical ventilation? Study design Multi-center Double blinded RCT Population Characteristics of study participants 39.2% female N = 3800 60.8% male 3800 patients (1454 female, 2259 male) Inclusion criteria: patients with septic shock undergoing mechanical ventilation Key exclusion criteria: systemic corticosteroids for an indication other than septic shock, etomidate treatment during current hospital admission, severely ill from preexisting disease and likely die within 90 days of randomization, or treatment limitations in place Interventions N=1832 hydrocortisone (continuous intravenous infusion at a dose of 200 mg per day for 7 days) N=1826 placebo (identical, masked 200 mL continuous intravenous infusion for 7 days) Primary outcome Death at 90 days https://web.pathway.md/studies/recMHx7JePVkSPnvX 1/2 6/28/23, 12:03 AM ADRENAL Pathway 28.8 % 28.8 27.9 21.6 % 14.4 % 7.2 % No significant difference 0.0 % Hydrocortisone Placebo No significant difference in death at 90 days (27.9% vs. 28.8%; HR 0.95, 95% CI 0.82 to 1.1) Secondary outcomes Significant decrease in median time to resolution of shock (3 days vs. 4 days; HR 0.76, 95% CI 0.71 to 0.81) Significant decrease in median time to discharge from ICU (10 days vs. 12 days; HR 0.86, 95% CI 0.81 to 0.94) Significant decrease in blood transfusion (37% vs. 41.7%; OR 0.82, 95% CI 0.72 to 0.94) Safety outcomes No significant difference in new-onset bacteremia or fungemia. Significant differences in overall adverse events (1.1% vs. 0.3%, p = 0.009). Conclusion In patients with septic shock undergoing mechanical ventilation, hydrocortisone was not superior to placebo with respect to death at 90 days. Reference Venkatesh B, Finfer S, Cohen J et al. Adjunctive Glucocorticoid Therapy in Patients with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):797-808. Open reference URL https://web.pathway.md/studies/recMHx7JePVkSPnvX 2/2