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Trial registered on ANZCTR


Registration number
ACTRN12608000053325
Ethics application status
Approved
Date submitted
25/01/2008
Date registered
29/01/2008
Date last updated
15/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial
Scientific title
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
Universal Trial Number (UTN)
Trial acronym
ARISE RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe sepsis 2768 0
Condition category
Condition code
Infection 2899 2899 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2507 0
Treatment: Other
Comparator / control treatment
Randomised allocation of standard care at the clinician's discretion in accordance with current best practice. Standard treatment may involve treatment with intravenous fluids, and medications to support the blood pressure and heart. Treatment is not given according to a protocol and may include some of the treatments given in the EGDT arm.
Control group
Active

Outcomes
Primary outcome [1] 3780 0
Death from all causes
Timepoint [1] 3780 0
28 days, ICU and hospital discharge and at 90 days
Secondary outcome [1] 6383 0
Duration of Emergency Department (ED) stay
Timepoint [1] 6383 0
28 and 90 days
Secondary outcome [2] 6394 0
Duration of Intensive Care Unit (ICU) stay
Timepoint [2] 6394 0
28 and 90 days
Secondary outcome [3] 6395 0
Duration of hospital stay
Timepoint [3] 6395 0
28 days and 90 days
Secondary outcome [4] 6396 0
The need for, and duration of, artificial organ support
Timepoint [4] 6396 0
6hours, 72 hours, 28 days and 90 days
Secondary outcome [5] 257637 0
Quality of life as measured by the Medical Outcomes Study Short Form 36 version 2 (SF-36v2), EuroQOL 5D (EQ-5D) and the Assessment of Quality of Life (AQoL) questionnaires
Timepoint [5] 257637 0
6 months and 12 months post randomisation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation using block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 561 0
3084
Recruitment outside Australia
Country [1] 771 0
New Zealand
State/province [1] 771 0
Country [2] 772 0
Hong Kong
State/province [2] 772 0

Funding & Sponsors
Funding source category [1] 3018 0
Government body
Name [1] 3018 0
National Health and Medical Research Council
Country [1] 3018 0
Australia
Primary sponsor type
University
Name
Australian and New Zealand Intensive Care Research Centre
Address
Department of Epidemiology and Preventive Medicine, Monash University, The Alfred, Melbourne 3004 Victoria
Country
Australia
Secondary sponsor category [1] 2726 0
None
Name [1] 2726 0
Address [1] 2726 0
Country [1] 2726 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4974 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 4974 0
Level 8 HSB - Room 8322, Austin Hospital
145 Studley Road Heidelberg Victoria 3084
Ethics committee country [1] 4974 0
Australia
Date submitted for ethics approval [1] 4974 0
12/02/2008
Approval date [1] 4974 0
16/04/2008
Ethics approval number [1] 4974 0
Ethics committee name [2] 6173 0
Ethics of Human Research Committee
The Queen Elizabeth Hospital and Lyell McEwin Hospital
Ethics committee address [2] 6173 0
28 Woodville Road
Woodville South SA 5011
Ethics committee country [2] 6173 0
Australia
Date submitted for ethics approval [2] 6173 0
07/04/2008
Approval date [2] 6173 0
28/04/2008
Ethics approval number [2] 6173 0
New ethics HREC. Please modify.
Ethics committee name [3] 6174 0
Northern Sydney and Central Coast Health Human Research Ethics Committee
Ethics committee address [3] 6174 0
Level 4, Vindin House
Royal North Shore Hospital
Pacific Highway
St Leonards NSW 2065
Ethics committee country [3] 6174 0
Australia
Date submitted for ethics approval [3] 6174 0
03/04/2008
Approval date [3] 6174 0
19/06/2008
Ethics approval number [3] 6174 0
New ethics HREC. Please modify.
Ethics committee name [4] 6175 0
Royal Perth Hospital Ethics Committee
Ethics committee address [4] 6175 0
Royal Perth Hospital
Wellington Street
Perth WA 6000
Ethics committee country [4] 6175 0
Australia
Date submitted for ethics approval [4] 6175 0
13/05/2008
Approval date [4] 6175 0
25/08/2008
Ethics approval number [4] 6175 0
New ethics HREC. Please modify.

Summary
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.
Trial website
http://arise.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28332 0
Address 28332 0
Country 28332 0
Phone 28332 0
Fax 28332 0
Email 28332 0
Contact person for public queries
Name 11489 0
Alina Jovanovska
Address 11489 0
Department of Epidemiology and Preventive Medicine, Monash University
The Alfred
Melbourne 3004
Victoria
Country 11489 0
Australia
Phone 11489 0
(03) 9903 0280
Fax 11489 0
(03) 9903 0071
Email 11489 0
[email protected]
Contact person for scientific queries
Name 2417 0
Rinaldo Bellomo
Address 2417 0
Austin Hospital
145 Studley Road
Heidelberg 3084
Victoria
Country 2417 0
Australia
Phone 2417 0
(03) 9496 5992
Fax 2417 0
(03 9496 3932
Email 2417 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIARISE statistical analysis plan2013https://doi.org/10.1111/1742-6723.12116
Dimensions AIThe Australasian Resuscitation in Sepsis Evaluation (ARISE) trial statistical analysis plan2013https://doi.org/10.1016/s1441-2772(23)01791-x
N.B. These documents automatically identified may not have been verified by the study sponsor.