Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis
ARISE FLUIDS
1 other identifier
interventional
1,000
3 countries
50
Brief Summary
This multicentre, randomised controlled trial will enrol 1000 patients presenting with septic shock to the emergency department (ED) of participating hospitals in Australia and New Zealand. Participants will receive haemodynamic resuscitation with either a restricted fluids and early vasopressor regimen or a larger initial IV fluid volume with later introduction of vasopressors if required. Clinical care including the type of resuscitation fluid and vasopressor agent, will otherwise be in accordance with accepted standard care and according to clinician discretion. The study intervention will be delivered for at least 6 hours and up to 24 hours post-randomisation. Participants will be followed for up to 12 months and outcomes analysed on an intention-to-treat basis.
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 2021
Longer than P75 for phase_3
50 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
First Submitted
Initial submission to the registry
September 23, 2020
CompletedFirst Posted
Study publicly available on registry
September 30, 2020
CompletedStudy Start
First participant enrolled
October 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2026
ExpectedMarch 17, 2026
November 1, 2025
4.3 years
September 23, 2020
March 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days alive and out of hospital
the number of days alive and out of hospital at 90 days post randomization
From randomisation until 90 days post- randomization
Secondary Outcomes (8)
Mortality
From randomisation until 90 days post- randomization
Time from randomization until death
From randomisation until 90 days post- randomization
Days alive and at home
From randomisation until 90 days post- randomization
Ventilator-free days to day 28
From randomisation until 28 days post- randomization
Vasopressor-free days to day 28
From randomisation until 28 days post- randomization
- +3 more secondary outcomes
Other Outcomes (15)
Incidence of invasive mechanical ventilation
From randomisation until 90 days post- randomization
Duration of invasive mechanical ventilation
From randomisation until 90 days post- randomization
Incidence of acute renal replacement therapy
From randomisation until 90 days post- randomization
- +12 more other outcomes
Study Arms (2)
Vasopressor
ACTIVE COMPARATORa restricted fluids and early vasopressor strategy
Fluids
ACTIVE COMPARATORa larger intravenous (IV) fluid volume and later vasopressor strategy
Interventions
Cease IV fluid resuscitation. If persisting hypotension and/or hypoperfusion commence a vasopressor infusion (e.g. noradrenaline) and titrate according to local practice to achieve target MAP. The target MAP will be determined by the treating clinician. Reassess at least hourly for up to 6 hours post-randomisation, then as clinically required in conjunction with the protocol. Boluses of 250ml of IV fluids are permitted if deemed indicated by the treating clinician.
An fluid bolus of up to 1000ml will be administered over a maximum of 1 hour, if required, for persisting hypotension and/or hypoperfusion. Reassess at least hourly to 6 hours post-randomisation, then as clinically required in conjunction with the protocol. Further IV fluid boluses of 500ml are recommended as clinically indicated to achieve the target MAP. The target MAP will be determined by the treating clinician. Haemodynamic resuscitation will be guided by usual clinical assessment including vital signs, mentation, perfusion, and urine output until the treating clinician determines fluid resuscitation is no longer clinically required. A minimum of 2-3 L (30 ml/kg), including pre-randomisation fluids, is recommended within 3 hours of ED arrival consistent with the SSC guidelines, unless clinically contraindicated. Vasopressors may be commenced if blood pressure remains below target despite optimal fluid resuscitation as determined by the treating clinician.
Eligibility Criteria
You may qualify if:
- Clinically suspected infection;
- Systolic blood pressure (SBP) \<90 mm Hg or mean arterial pressure (MAP) \<65 mm Hg, despite a ⩾1000ml cumulative total bolus of IV fluid administered over a maximum of 60 minutes; including pre-hospital boluses;
- Arterial or venous blood lactate \>2.0 mmol/L;
- At least one dose of an intravenous antimicrobial has been commenced.
You may not qualify if:
- Age \<18 years;
- Confirmed or suspected pregnancy;
- Transferred from another acute care facility;
- Hypotension suspected to be due to a non-sepsis cause;
- \>2L total IV fluid administered (including prehospital fluids but excluding drugs and flushes);
- Treating clinician considers that one or both of the treatment regimens are not suitable for the patient or the study protocol cannot be delivered e.g. limitation of care, requirement for immediate surgery;
- Death is considered imminent or inevitable;
- Underlying disease that makes survival to 90 days unlikely;
- Inability to follow patient up to day-90 e.g. unstable accommodation, overseas visitor;
- Previously enrolled in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Bankstown Hospital
Bankstown, New South Wales, 2200, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Nepean Hosital
Kingswood, New South Wales, 2747, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444, Australia
Royal North Shore Hosptial
Sydney, New South Wales, 2065, Australia
Ryde Hospital
Sydney, New South Wales, 2112, Australia
Tamworth Hospital
Tamworth, New South Wales, 2340, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Darwin & Palmerston Hospital
Darwin, Northern Territory, 0811, Australia
The Prince Charles Hospital
Brisbane, Queensland, 4032, Australia
QE II Jubilee Hospital
Brisbane, Queensland, 4108, Australia
Bundaberg Hospital
Bundaberg, Queensland, 4670, Australia
Caboolture Hospital
Caboolture, Queensland, 4510, Australia
Cairns Hospital
Cairns, Queensland, 4870, Australia
Hervey Bay Hospital
Hervey Bay, Queensland, 4655, Australia
Ipswich Hospital
Ipswich, Queensland, 4305, Australia
Mackay Base Hospital
Mackay, Queensland, 4740, Australia
Robina Hospital
Robina, Queensland, 4226, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Sunshine Coast university hospital
Sunshine Coast, Queensland, 4560, Australia
Toowoomba Hospital
Toowoomba, Queensland, 4350, Australia
Townsville Hospital
Townsville, Queensland, 4810, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011, Australia
Flinders Medical Centre
Streaky Bay, South Australia, 5025, Australia
Ballarat Base Hospital
Ballarat, Victoria, 3353, Australia
Bendigo Hospital
Bendigo, Victoria, 3550, Australia
Casey Hospital
Berwick, Victoria, 3806, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Dandenong Hospital
Dandenong, Victoria, Australia
Northern Hospital
Epping, Victoria, 3076, Australia
Angliss Hospital
Ferntree Gully, Victoria, 3156, Australia
St. Vincent's Hospital
Fitzroy, Victoria, 3065, Australia
Barwon Health Geelong Hospital
Geelong, Victoria, 3220, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Maroondah Hospital
Ringwood East, Victoria, 3135, Australia
Wangaratta Hospital
Wangaratta, Victoria, 3677, Australia
Bunbury Hospital
Bunbury, Western Australia, 6230, Australia
St John of God Hospital
Midland, Western Australia, 6056, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, 6150, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Fiona Stanley Hospital
Perth, Western Australia, 6150, Australia
St. Vincent's University Hospital
Elm Park, Dublin, D04 T6F4, Ireland
Auckland City Hospital
Auckland, North Island, 1023, New Zealand
Dunedin Hospital
Dunedin, Otago, 9054, New Zealand
Middlemore Hospital
Middlemore, Otahuhu, 1640, New Zealand
Taranki Hospital
Hawera, 4640, New Zealand
Wellington Hospital
Wellington, 2820, New Zealand
Related Publications (1)
Howe BD, Macdonald SPJ, Arendts G, Bellomo R, Burcham J, Delaney A, Egerton-Warburton D, Fatovich D, Fraser JF, Higgins A, Jones P, Keijzers G, Milford E, Udy AA, Williams P, Young P, Peake SL. Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol. BMJ Open. 2025 Jul 20;15(7):e101215. doi: 10.1136/bmjopen-2025-101215.
PMID: 40685240DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sandra Peake, MBBS
Monash University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2020
First Posted
September 30, 2020
Study Start
October 26, 2021
Primary Completion
February 1, 2026
Study Completion (Estimated)
November 3, 2026
Last Updated
March 17, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- IPD will be available one year after the publication date for a 2 year period
- Access Criteria
- Data requests can be submitted to the ARISE FLUIDS Management Committee, via the project manager, Ms Belinda Howe, at belinda.howe@monash.edu. The data will be made available following the submission of an appropriate research question, approval of the application by the ARISE FLUIDS management committee, and execution of a data sharing agreement.
all IPD that underlie results in a publication