• Alisa M Higgins, Sandra L Peake, Rinaldo Bellomo, D Jamie Cooper, Anthony Delaney, Anthony H Harris, Belinda D Howe, Alistair D Nichol, Steve A Webb, Patricia J Williams, and Australasian Resuscitation in Sepsis Evaluation (ARISE) Investigators and the ANZICS Clinical Trials Group.
• Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
• Crit. Care Med. 2019 Jun 1; 47 (6): 765-773.

ObjectivesTo examine long-term survival and quality of life of patients with early septic shock.DesignProspective, randomized, parallel-group trial.SettingFifty-one hospitals in Australia, New Zealand, Finland, Hong Kong, and the Republic of Ireland.PatientsOne-thousand five-hundred ninety-one patients who presented to the emergency department with early septic shock between October 2008 and April 2014, and were enrolled in the Australasian Resuscitation in Sepsis Evaluation trial.InterventionsEarly goal-directed therapy versus usual care.Measurements And Main ResultsLong-term survival was measured up to 12 months postrandomization. Health-related quality of life was measured using the EuroQoL-5D-3L, Short Form 36 and Assessment of Quality of Life 4D at baseline, and at 6 and 12 months following randomization. Mortality data were available for 1,548 patients (97.3%) and 1,515 patients (95.2%) at 6 and 12 months, respectively. Health-related quality of life data were available for 85.1% of survivors at 12 months. There were no significant differences in mortality between groups at either 6 months (early goal-directed therapy 21.8% vs usual care 22.6%; p = 0.70) or 12 months (early goal-directed therapy 26.4% vs usual care 27.9%; p = 0.50). There were no group differences in health-related quality of life at either 6 or 12 months (EuroQoL-5D-3L utility scores at 12 mo early goal-directed therapy 0.65 ± 0.33 vs usual care 0.64 ± 0.34; p = 0.50), with the health-related quality of life of both groups being significantly lower than population norms.ConclusionsIn patients presenting to the emergency department with early septic shock, early goal-directed therapy compared with usual care did not reduce mortality nor improve health-related quality of life at either 6 or 12 months.

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