6/28/23, 11:07 PM HYPRESS Pathway Feedback Search Clinical Topics Home Studies HYPRESS HYPRESS Disease Sepsis and septic shock Trial question What is the effect of hydrocortisone on the development of shock among patients with severe sepsis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 35.5% female N = 380 64.5% male 380 patients (124 female, 229 male) Inclusion criteria: patients with severe sepsis Key exclusion criteria: septic shock, younger than 18 years, known hypersensitivity to hydrocortisone or mannitol (placebo), history of corticosteroid medication with indication for continuation of therapy or other indications for treatment with corticosteroids Interventions N=190 hydrocortisone (continuous infusion at a dose of 200 mg for 5 days followed by dose tapering until day 11) N=190 placebo (lyophilized mannitol) Primary outcome Rate of septic shock within 14 days 22.9 22 9 % 21 2 https://web.pathway.md/studies/reczdwroms4DHgnNv 1/2 6/28/23, 11:07 PM 22.9 % HYPRESS Pathway 21.2 17.2 % 11.4 % 5.7 % No significant difference 0.0 % Hydrocortisone Placebo No significant difference in the rate of septic shock within 14 days (21.2% vs. 22.9%; AD -1.8%, 95% CI -10.7 to 7.2) Secondary outcomes No significant difference in death at 28 days (8.8% vs. 8.2%; AD 0.5%, 95% CI -5.6 to 6.7) No significant difference in death at 90 days (19.9% vs. 16.7%; AD 3.2%, 95% CI -5.1 to 11.4) No significant difference in death at 180 days (26.8% vs. 22.2%; AD 4.6%, 95% CI -4.6 to 13.7) Safety outcomes No significant differences in secondary infections, weaning failure, muscle weakness, hypernatremia, or other adverse events. Significant differences in hyperglycemia (90.9% vs. 81.5%), delirium (8.5% vs. 19.2%). Conclusion In patients with severe sepsis, hydrocortisone was not superior to placebo with respect to the rate of septic shock within 14 days. Reference Keh D, Trips E, Marx G et al. Effect of Hydrocortisone on Development of Shock Among Patients With Severe Sepsis: The HYPRESS Randomized Clinical Trial. JAMA. 2016 Nov 1;316(17):1775-1785. Open reference URL https://web.pathway.md/studies/reczdwroms4DHgnNv 2/2