Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial
ARISE
A Multi-centre, Randomised Controlled Trial of Early Goal-directed Therapy in Patients Presenting to the Emergency Department With Severe Sepsis in Australasia
2 other identifiers
interventional
1,600
5 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2008
Longer than P75 for phase_3
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 10, 2009
CompletedFirst Posted
Study publicly available on registry
September 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 24, 2014
April 1, 2014
5.8 years
September 10, 2009
April 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure for the study is death from all causes
90 days
Secondary Outcomes (4)
Death from all causes
28 days, and at ICU and hospital discharge
Quality of life as measured by the SF-36v2, EQ-5D and the AQoL
6 and 12 months post-randomisation
Duration of ED, ICU and hospital stay
28 days and 90 days
The need for, and duration of, artificial organ support
28 days and 90 days
Study Arms (2)
Standard Care
NO INTERVENTIONRandomised allocation of standard care at the clinician's discretion in accordance with current best practice.
Early Goal Directed Therapy
EXPERIMENTALRandomised allocation of early goal-directed therapy (EGDT).
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.
Eligibility Criteria
You may qualify if:
- Suspected or confirmed infection
- The presence of TWO or MORE of the following SIRS criteria:
- Core temperature \< 36.0 degC or \> 38.0 degC
- Heart rate \> 90 beats/minute
- Respiratory rate \> 20 breaths/minute or PaCO2 \< 32 mmHg or the requirement for mechanical ventilation for an acute process
- White blood cell count \> 12.0 or \< 4.0 x109/L or \> 10% immature band forms
- Evidence of either refractory hypotension OR hypoperfusion:
- Refractory hypotension is confirmed by the presence of a systolic blood pressure (SBP) \< 90 mmHg or mean arterial pressure (MAP) \< 65 mmHg after a 1000ml intravenous (IV) fluid challenge within 60 minutes (including IV fluids administered pre-hospital)
- Hypoperfusion is confirmed by the presence of a blood lactate concentration greater than or equal to 4.0 mmol/L
- First dose of IV antimicrobial therapy commenced prior to randomisation
You may not qualify if:
- Age \< 18 years
- Contra-indication to superior vena cava (SVC) CVC insertion
- Contra-indication to blood products (e.g. Jehovah's Witness)
- Inability to commence delivery of the EGDT protocol within 1 hour of randomisation or complete 6 hours of EGDT
- Haemodynamic instability due to active bleeding
- Pregnancy (confirmed or suspected)
- In-patient transfer from another acute health care facility
- 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 restricting implementation of the study protocol or the treating clinician deems aggressive care unsuitable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Canberra Hospital
Garran, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Coffs Harbour Hospital
Coffs Harbour, New South Wales, Australia
St Vincent's Hospital (Sydney)
Darlinghurst, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
Hornsby Hospital
Hornsby, New South Wales, Australia
Manly Hospital
Manly, New South Wales, Australia
John Hunter Hospital
Newcastle, New South Wales, Australia
Nepean Hospital
Penrith, New South Wales, Australia
Port Macquarie Base
Port Macquarie, New South Wales, Australia
Prince of Wales Hospital (Sydney)
Randwick, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, 2065, Australia
Liverpool Hospital
Sydney, New South Wales, 2170, Australia
Sydney Adventist hospital
Sydney, New South Wales, Australia
Tamworth Hospital
Tamworth, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Townsville Hospital
Douglas, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston Brisbane, Queensland, Australia
Ipswich Hospital
Ipswich, Queensland, Australia
Logan Hospital
Meadowbrook, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Princess Alexandra
Woolloongabba, Queensland, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Modbury Hospital
Modnury, South Australia, Australia
Bendigo Hospital
Bendigo, Victoria, Australia
Blacktown Hospital
Blacktown, Victoria, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Dandenong Hospital
Dandenong, Victoria, Australia
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Geelong Hospital
Geelong, Victoria, Australia
Austin Hospital
Melbourne, Victoria, 3084, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
The Alfred
Prahan, Victoria, Australia
Central Gippsland (Sale Hospital)
Sale, Victoria, Australia
Joondalup Health Campus
Joondalup, Western Australia, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, 6001, Australia
Helsinki University Hospital
Helsinki, Finland, Finland
Tampere University Hospital
Tampere, Finland, Finland
Prince of Wales Hospital
Hong Kong, Hong Hong, Hong Kong
Pamela Youde Nethersole Eastern Hospital (HK)
Chai Wan, Hong Kong, Hong Kong
The Queen Elizabeth Hospital (HK)
Kowloon, Hong Kong, Hong Kong
St. Vincent's University hospital
Dublin, Ireland
Middlemore Hospital
Otahuhu Auckland, Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand, New Zealand
Auckland City Hospital
Auckland, New Zealand
Related Publications (4)
Higgins AM, Peake SL, Rinaldo Bellomo AO, Ao DJC, Delaney A, Howe BD, Nichol AD, Webb SA, Williams PJ, Harris AH; ARISE Investigators and the ANZICS Clinical Trials Group. The cost-effectiveness of early goal-directed therapy: an economic evaluation alongside the ARISE trial. Crit Care Resusc. 2023 Oct 18;23(3):329-336. doi: 10.51893/2021.3.OA10. eCollection 2021 Sep 6.
PMID: 38046082DERIVEDHiggins AM, Peake SL, Bellomo R, Cooper DJ, Delaney A, Harris AH, Howe BD, Nichol AD, Webb SA, Williams PJ; Australasian Resuscitation in Sepsis Evaluation (ARISE) Investigators and the ANZICS Clinical Trials Group. Quality of Life and 1-Year Survival in Patients With Early Septic Shock: Long-Term Follow-Up of the Australasian Resuscitation in Sepsis Evaluation Trial. Crit Care Med. 2019 Jun;47(6):765-773. doi: 10.1097/CCM.0000000000003762.
PMID: 30985391DERIVEDARISE Investigators; ANZICS Clinical Trials Group; Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. doi: 10.1056/NEJMoa1404380. Epub 2014 Oct 1.
PMID: 25272316DERIVEDDelaney A, Peake SL, Bellomo R, Cameron P, Holdgate A, Howe B, Higgins A, Presneill J, Webb S; ARISE Investigators. Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan. Emerg Med Australas. 2013 Oct;25(5):406-15. doi: 10.1111/1742-6723.12116. Epub 2013 Sep 9.
PMID: 24099368DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rinaldo Bellomo
Austin Hospital, Melbourne Australia
- STUDY CHAIR
Sandra L Peake
The Queen Elizabeth Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Project manager, ANZIC- Research Centre, Monash University
Study Record Dates
First Submitted
September 10, 2009
First Posted
September 11, 2009
Study Start
October 1, 2008
Primary Completion
July 1, 2014
Study Completion
April 1, 2015
Last Updated
April 24, 2014
Record last verified: 2014-04