Severe Sepsis Clinical Trial
Official title:
A Multi-centre, Randomised Controlled Trial of Early Goal-directed Therapy in Patients Presenting to the Emergency Department With Severe Sepsis in Australasia
The ARISE RCT is a multi-centre, randomised, controlled trial of EGDT compared to standard
care in patients with severe sepsis presenting to the ED. The study will be conducted in
multiple sites with 1600 patients enrolled into the study.
Hypothesis to be tested: EGDT, compared to standard Australasian resuscitation practice,
reduces 90-day all-cause mortality in patients presenting to the ED with severe sepsis.
The primary aim of the study is to determine whether providing EGDT, compared to standard
care, reduces 90-day mortality in patients presenting to the ED of hospitals in Australasia
with severe sepsis.
Each patient meeting all of the exclusion criteria and none of the exclusion criteria will
be randomised in the ED to receive either EGDT for a total of 6 hours post-randomisation, or
standard care.
Patients assigned to receive EGDT will be cared for by the dedicated ARISE study team. The
patient will receive treatment as per the study protocol for 6 hours with central blood
oxygen levels as the target end-point, then receive standard care.
Patients assigned to receive standard care will continue to be cared for by the hospital
team in accordance with current best practice.
Patients in both groups will also receive any additional treatment needed, such as
antibiotics or surgery.
This study will involve 1600 patients with severe sepsis admitted to the ED from multiple
hospitals.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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