6/28/23, 12:43 AM APROCCHSS Pathway Feedback Search Clinical Topics Home Studies APROCCHSS APROCCHSS Disease Sepsis and septic shock Trial question What is the role of hydrocortisone and fludrocortisone in adult patients with septic shock? Study design Multi-center Double blinded RCT Population Characteristics of study participants 33.0% female N = 1241 67.0% male 1241 patients (415 female, 826 male) Inclusion criteria: patients with septic shock Key exclusion criteria: presence of septic shock for at least 24 hours, a high risk of bleeding, pregnancy or lactation, underlying conditions that could affect short-term survival, or previous treatment with corticosteroids Interventions N=614 hydrocortisone and fludrocortisone (hydrocortisone 50 mg IV q6h plus fludrocortisone 50 g PO/VL daily) N=627 placebo (matching placebo) Primary outcome https://web.pathway.md/studies/recy73JgX1tmzWPTE 1/2 6/28/23, 12:43 AM APROCCHSS Pathway Death at 90 days 49.0 % 49 43 36.8 % 24.5 % Significant decrease 12.3 % NNT = 17 0.0 % Hydrocortisone and fludrocortisone Placebo Significant decrease in death at 90 days (43% vs. 49%; RR 0.88, 95% CI 0.08 to 1.68) Secondary outcomes No significant difference in death at 28 days (34% vs. 39%; RR 0.87, 95% CI 0.75 to 1.01) Significant decrease in ICU mortality (35% vs. 41%; RR 0.86, 95% CI 0.75 to 0.99) Significant decrease in in-hospital mortality (39% vs. 45%; RR 0.86, 95% CI 0.76 to 0.98) Safety outcomes No significant differences in serious adverse events, bleeding, rate or site of superinfection, new- onset sepsis or septic shock, or neurologic sequelae. Significant difference in hyperglycemia (89% vs. 83%). Conclusion In patients with septic shock, hydrocortisone and fludrocortisone were superior to placebo with respect to death at 90 days. Reference Djillali Annane, Alain Renault, Christian Brun-Buisson et al. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. Open reference URL https://web.pathway.md/studies/recy73JgX1tmzWPTE 2/2