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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000053325

Acronym

ARISE RCT

Enrollment

1600

Registered

2008-01-29

Start date

2008-10-06

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Suspected or confirmed infection 2. 2 or more systemic inflammatory response syndrome (SIRS) criteria 3. Evidence of either refractory hypertension or hypoperfusion

Exclusion criteria

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

Outcome results