Australasian Resuscitation In Sepsis Evaluation Randomised Controlled Trial
NCT ID: NCT00975793
Last Updated: 2014-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
1600 participants
INTERVENTIONAL
2008-10-31
2015-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis
NCT04569942
Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS
NCT05238532
Droplet Digital PCR Combines With Transcriptome Analysis in Early Warning of Sepsis in the Emergency Department
NCT06028178
Effect of EGDT on Hepatic Perfusion in Patients With Septic Shock
NCT02060773
Clinical Trial of the Optimal Endpoint of Early Sepsis Resuscitation
NCT00372502
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard Care
Randomised allocation of standard care at the clinician's discretion in accordance with current best practice.
No interventions assigned to this group
Early Goal Directed Therapy
Randomised allocation of early goal-directed therapy (EGDT).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Australian and New Zealand Intensive Care Society Clinical Trials Group
NETWORK
Australasian College for Emergency Medicine
OTHER
Belinda Howe
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Belinda Howe
Project manager, ANZIC- Research Centre, Monash University
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rinaldo Bellomo
Role: PRINCIPAL_INVESTIGATOR
Austin Hospital, Melbourne Australia
Sandra L Peake
Role: STUDY_CHAIR
The Queen Elizabeth Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, Australia
Liverpool Hospital
Sydney, New South Wales, 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, 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, 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, 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Higgins 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.
ARISE 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.
Delaney 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NHMRC Project grant no. 491075
Identifier Type: -
Identifier Source: secondary_id
ANZIC - RC/RB001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.