The ARISE Trial
Goal-Directed Resuscitation for Patients with Early Septic Shock. The ARISE Investigators and the ANZICS Clinical Trials Group. New England Journal of Medicine. 2014 Oct 16. The Idea: Assess the effectiveness of early goal directed therapy in sepsis, as outlined in the Surviving Sepsis Campaign, in populations outside of the United States, in both academic and community hospitals.
1600 patients from 51 centers, including 3° and non-3° centers in rural and urban settings from 5 countries, with severe sepsis were randomized to EGDT or “usual care” following the administration of antibiotics in the ED. Interventions for the first 6 hours were based on the EGDT algorithm for the EGDT group, while the treating team made decisions on appropriate interventions in the “usual care” group. The primary outcome was all cause mortality at 90 days.
The Findings: While the EGDT group received more vasopressor support and more frequent blood transfusions, there was no difference in 90-day mortality between the two groups. There was also no difference in various secondary outcomes such as total fluid administration, length of stay, in-hospital mortality, or need for organ support.
The takeaway: The ARISE trail re-demonstrated what was seen in the PROCESS trial by showing that “usual care”, with early detection of sepsis, prompt administration of antibiotics, and aggressive fluid resuscitation, leads to similar patient centered outcomes as EGDT. Additionally, ARISE shows that “usual care” applied in different countries, in both rural and urban centers, and across academic and community institutions leads to similar patient outcomes.