6/28/23, 12:44 AM ARISE Pathway Feedback Search Clinical Topics Home Studies ARISE ARISE Disease Sepsis and septic shock Trial question What is the role of early goal-directed therapy in critically ill patients with early septic shock? Study design Multi-center Open label RCT Population Characteristics of study participants 40.4% female N = 1600 59.6% male 1600 patients (641 female, 950 male) Inclusion criteria: patients presenting to the emergency department with early septic shock Key exclusion criteria: age < 18 years, contraindication to central venous catheter insertion in the superior vena cava, contraindication to receiving blood products, hemodynamic instability due to active bleeding, underlying disease process with a life expectancy < 90 days, death deemed imminent and inevitable, confirmed or suspected pregnancy Interventions N=796 early goal-directed therapy (in the first 6 hour period) N=804 standard of care (in the first 6 hour period) Primary outcome https://web.pathway.md/studies/recsYafocutxooYu1 1/2 6/28/23, 12:44 AM ARISE Pathway Death at 90 days 18.8 % 18.8 18.6 14.1 % 9.4 % 4.7 % No significant difference 0.0 % Early goal-directed therapy Standard of care No significant difference in death at 90 days (18.6% vs. 18.8%; RR 0.98, 95% CI 0.8 to 1.21) Secondary outcomes No significant difference in death at 28 days (14.8% vs. 15.9%; RR 0.93, 95% CI 0.73 to 1.17) Safety outcomes No significant differences in 1 adverse events (7.1% vs. 5.3%, p=0.15). Conclusion In patients presenting to the emergency department with early septic shock, early goal-directed therapy was not superior to standard of care with respect to death at 90 days. Reference ARISE Investigators, ANZICS Clinical Trials Group, Peake SL et al. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. Open reference URL https://web.pathway.md/studies/recsYafocutxooYu1 2/2