Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial
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 in Australasia
Australian and New Zealand Intensive Care Research Centre
1,600 participants
Oct 6, 2008
Interventional
Conditions
Summary
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. The study will be conducted in 32 hospitals in Australasia with 1600 patients enrolled in the study over a 2.5 year period.
Eligibility
Inclusion Criteria3
- Suspected or confirmed infection
- 2 or more systemic inflammatory response syndrome (SIRS) criteria
- Evidence of either refractory hypertension or hypoperfusion
Exclusion Criteria1
- Contra-indication to superior vena cava central venous catheter insertion; contra-indication to blood products; inability to commence delivery of EGDT protocol within 1 hour of randomisation or complete 6 hours of EGDT; haemodynamic instability due to active bleeding; pregnancy; transfer from another ED or acute health care facility; the patient has an underlying disease process with a life expectancy of < 90 days; death is deemed imminent and inevitable; a "limitation of therapy" order has been documented
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Interventions
Randomised allocation of early goal-directed therapy (EGDT). EGDT involves treatment with intravenous fluids, and medications to support the blood pressure and heart following a protocol. A special catheter is inserted to monitor central blood oxygen levels and the standard treatments are given according to the blood oxygen level reading. EGDT is given for 6 hours, then the patient receives standard care.
Locations(2)
View Full Details on ANZCTR
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ACTRN12608000053325