The ARISE RCT was a multi-centre, randomised controlled trial of the effect of early goal-directed therapy, compared to standard care, on 90-day mortality in patients presenting to the Emergency Department with severe sepsis.
Patients were randomised in the ED to receive either EGDT for a total of 6 hours post-randomisation, or standard care. Patients assigned to receive EGDT were cared for by the dedicated ARISE study team. The patient received treatment as per the study protocol for 6 hours with central blood oxygen levels as the target end-point, and then received standard care. Patients assigned to receive standard care continued to be cared for by the hospital team in accordance with current best practice. Patients in both groups received any additional treatment needed, such as antibiotics or surgery.
The study was conducted in multiple sites with 1600 patients enrolled in the study over a 2.5 year period