6/29/23, 1:45 AM PROWESS-SHOCK Pathway Feedback Search Clinical Topics Home Studies PROWESS SHOCK PROWESS SHOCK Disease Sepsis and septic shock Trial question What is the role of drotrecogin alfa (activated) in patients with septic shock? Study design Multi-center Double blinded RCT Population Characteristics of study participants 44.0% female N = 1697 56.0% male 1697 patients (739 female, 957 male) Inclusion criteria: patients with infection, systemic inflammation, and shock who were receiving fluids and vasopressors above a threshold dose for 4 hours Key exclusion criteria: age < 18 years, no evidence of infection, coexisting illnesses with a high risk of death (e.g., metastatic cancer), major bleeding, pregnant or lactating, INR > 5.0, or sepsis induced organ dysfunction > 36 hours Interventions N=846 drotrecogin alfa activated (24 g/kg of body weight per hour for 96 hours) N=834 placebo (matching placebo for 96 hours) Primary outcome https://web.pathway.md/studies/recu2vSho1XZfsinm 1/2 6/29/23, 1:45 AM PROWESS-SHOCK Pathway Death at 28 days 26.4 % 26.4 24.2 19.8 % 13.2 % 6.6 % No significant difference 0.0 % Drotrecogin alfa activated Placebo No significant difference in death at 28 days (26.4% vs. 24.2%; RR 1.09, 95% CI 0.92 to 1.28) Secondary outcomes No significant difference in death at 90 days (34.1% vs. 32.7%; RR 1.04, 95% CI 0.9 to 1.19) No significant difference in death at 28 days, among patients with severe protein C deficiency (28.7% vs. 30.8%; RR 0.93, 95% CI 0.74 to 1.17) Safety outcomes No significant differences in serious bleeding (1.2% vs. 1.0%, p=0.81) and serious adverse events (14.3% vs. 11.5%, p=0.10). Conclusion In patients with infection, systemic inflammation, and shock who were receiving fluids and vasopressors above a threshold dose for 4 hours, drotrecogin alfa activated was not superior to placebo with respect to death at 28 days. Reference Ranieri VM, Thompson BT, Barie PS et al. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012 May 31;366(22):2055-64. Open reference URL https://web.pathway.md/studies/recu2vSho1XZfsinm 2/2