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Australasian Resuscitation in Sepsis Evaluation (ARISE) Observational Study
The ARISE Observational Study was a 3-month audit of severe sepsis resuscitation practices in Emergency Departments (EDs) across Australia and New Zealand. The study was undertaken to provide data to support an NHMRC grant submission to conduct a phase III multi-centre randomised controlled trial of early goal-directed therapy administered in the Emergency Department for severe sepsis. The ARISE Observational Study was completed in January 2007. This study resulted in a successful NHMRC grant application to fund a large multi-centre randomised controlled trial of EGDT in severe sepsis in Australasia (ARISE-RCT).
Rationale: Severe sepsis is a major public 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.
Findings: 324 patients (52.5% male) of median age 66 years (IQR 50, 79) and median APACHE II score 18.0 (IQR 13.0, 24.5) were enrolled from 32 sites. Pneumonia (42.6%) and urinary tract infection (30.2%) were the commonest causes of severe sepsis. Between T0 (enrolment) and T+6 hours, 44.4% received an intra-arterial, 37 % a central venous and no patients a continuous central venous oxygen saturation catheter. Between T0 and T+6 hours, a vasoactive infusion was commenced in 30.2 %, a red blood cell transfusion in 7.7%, and a dobutamine infusion in 2.5%. In the same time period, 52.6% were admitted to ICU and18.8% had invasive ventilation. Overall hospital mortality was 20.1% and was not different between patients admitted to ICU (18.9%) and the general ward (20.4%).
The management of patients presenting to ED with severe sepsis does not include Early Goal-Directed Therapy (EGDT). Hospital mortality was lower than previously reported and the baseline mortality of severe sepsis in Australia and New Zealand was much lower than in the 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; 345:1368-1377). Reliable estimates of sample size and recruitment rate for a proposed multi-centre trial in Australia and New Zealand were obtained and it was confirmed that this would be feasible.
Publications: The publications relating to this study include:
Peake S, Bailey M, Bellomo R, Cameron P, Cross A, Delaney A, Finfer S, Higgins A, Jones D, Myburgh J, Syres G, Webb S, Williams P, the ARISE Investigators for the ANZICS-CTG. Australasian Resuscitation of Sepsis Evaluation (ARISE): A multi-centre prospective, inception cohort study. Resuscitation 2009; 80: 811-18. IF 2.51.
Endorsement: The ARISE Observational Study was endorsed by the ANZICS-CTG.
