ARISE-RCT: Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial
The ARISE-RCT is a multi-centre, unblinded, randomised, controlled trial of Early Goal-Directed Therapy (EGDT®) versus standard care in patients with severe sepsis presenting to the Emergency Departments (EDs) of hospitals in Australia, New Zealand, Finland and Hong Kong.
Goal: The study will test the hypothesis that EGDT®, compared to standard care, reduces 90-day mortality in patients presenting to the ED with severe sepsis. The null hypothesis is that there is no difference in the risk of death between patients assigned to either EGDT® or standard care. The ARISE-RCT, along with the NIH-funded PROCESS trial, will look to validate the findings of the single-centre Rivers et al. study (Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001;345:1368-77).
Rationale: Severe sepsis is a major publich health problem. In 2004, the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) reported that the adult incidence of severe sepsis (a complication of severe infection) is 77 cases per 100,000 of population per year in Australia and New Zealand; representing over 15,000 patient episodes per year. Similar population incidence rates have been reported elsewhere. Importantly, 11.8% of all admissions to Australian and New Zealand ICUs are associated with severe sepsis and in-hospital mortality is 37.5%. In patients with septic shock, mortality approaches 60%. The burden of death is approximately 3 times the annual national road toll. The death rate also exceeds other diseases which significantly impact on the Australian community such as breast and colorectal cancer. Given the pressing need to reduce the mortality from severe sepsis and the class II evidence that EGDT may be an effective treatment that is not currently used in the majority of Australian and New Zealand hospitals, a phase III study to examine the effectiveness of EGDT in Australasian patients is imperative. Unless a trial specifically comparing EGDT and Australasian standard care is performed, ED and ICU specialists will remain uncertain about the benefits of EGDT to our patients and will be unlikely to adopt this potentially life-saving strategy.
Study Progress: As at December 2011 the ARISE-RCT is enrolling patients at 45 ICUs internationally and over 800 patients have been recruited. The enrolment target is 1,600 patients.
Collaboration: The ARISE-RCT is being conducted in collaboration with the Australasian College for Emergency Medicine (ACEM) Clinical Trials Group.
Endorsement: The ARISE-RCT is endorsed by the ANZICS CTG.
Contact: For further information about this study, please contact the ANZIC-RC ARISE-RCT Project Manager, Belinda Howe, by email.
Data Entry Website: https://arise.org.au