Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-30 @ 4:04 PM
Study NCT ID:
NCT00975793
Status:
UNKNOWN
Last Update Posted:
2014-04-24
First Post:
2009-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial
Sponsor:
Belinda Howe
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2014-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARISE
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NHMRC Project grant no. 491075 | None | None | View |