NCT00975793

Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial

A Multi-centre, Randomised Controlled Trial of Early Goal-directed Therapy in Patients Presenting to the Emergency Department With Severe Sepsis in Australasia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,600 (estimated)
• Sponsor: Belinda Howe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Severe Sepsis

Interventions

Type	Name	Description
OTHER	Early Goal Directed Therapy (EGDT)	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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2014-07-01
• Completion: 2015-04-01
• First posted: 2009-09-11
• Last updated: 2014-04-24

Locations

51 sites across 5 countries: Australia, Finland, Hong Kong, Ireland, New Zealand