Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial (ARISE)
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|ClinicalTrials.gov Identifier: NCT00975793|
Recruitment Status : Unknown
Verified April 2014 by Belinda Howe, Monash University.
Recruitment status was: Active, not recruiting
First Posted : September 11, 2009
Last Update Posted : April 24, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Sepsis||Other: Early Goal Directed Therapy (EGDT)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||July 2014|
|Estimated Study Completion Date :||April 2015|
No Intervention: Standard Care
Randomised allocation of standard care at the clinician's discretion in accordance with current best practice.
Experimental: Early Goal Directed Therapy
Randomised allocation of early goal-directed therapy (EGDT).
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.
- The primary outcome measure for the study is death from all causes [ Time Frame: 90 days ]
- Death from all causes [ Time Frame: 28 days, and at ICU and hospital discharge ]
- Quality of life as measured by the SF-36v2, EQ-5D and the AQoL [ Time Frame: 6 and 12 months post-randomisation ]
- Duration of ED, ICU and hospital stay [ Time Frame: 28 days and 90 days ]
- The need for, and duration of, artificial organ support [ Time Frame: 28 days and 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975793
|Principal Investigator:||Rinaldo Bellomo||Austin Hospital, Melbourne Australia|
|Study Chair:||Sandra L Peake||The Queen Elizabeth Hospital|