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Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis
Sponsor: Australian and New Zealand Intensive Care Research Centre
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2021-10-26
Completion Date
2026-11-03
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
Vasopressor
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.
Fluids
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.
Locations (50)
Bankstown Hospital
Bankstown, New South Wales, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Nepean Hosital
Kingswood, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Royal North Shore Hosptial
Sydney, New South Wales, Australia
Ryde Hospital
Sydney, New South Wales, Australia
Tamworth Hospital
Tamworth, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Darwin & Palmerston Hospital
Darwin, Northern Territory, Australia
The Prince Charles Hospital
Brisbane, Queensland, Australia
QE II Jubilee Hospital
Brisbane, Queensland, Australia
Bundaberg Hospital
Bundaberg, Queensland, Australia
Caboolture Hospital
Caboolture, Queensland, Australia
Cairns Hospital
Cairns, Queensland, Australia
Hervey Bay Hospital
Hervey Bay, Queensland, Australia
Ipswich Hospital
Ipswich, Queensland, Australia
Mackay Base Hospital
Mackay, Queensland, Australia
Robina Hospital
Robina, Queensland, Australia
Gold Coast University Hospital
Southport, Queensland, Australia
Sunshine Coast university hospital
Sunshine Coast, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Townsville Hospital
Townsville, Queensland, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Streaky Bay, South Australia, Australia
Ballarat Base Hospital
Ballarat, Victoria, Australia
Bendigo Hospital
Bendigo, Victoria, Australia
Casey Hospital
Berwick, Victoria, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Dandenong Hospital
Dandenong, Victoria, Australia
Northern Hospital
Epping, Victoria, Australia
Angliss Hospital
Ferntree Gully, Victoria, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
Barwon Health Geelong Hospital
Geelong, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Maroondah Hospital
Ringwood East, Victoria, Australia
Wangaratta Hospital
Wangaratta, Victoria, Australia
Bunbury Hospital
Bunbury, Western Australia, Australia
St John of God Hospital
Midland, Western Australia, Australia
St John of God Murdoch Hospital
Murdoch, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Fiona Stanley Hospital
Perth, Western Australia, Australia
St. Vincent's University Hospital
Elm Park, Dublin, Ireland
Auckland City Hospital
Auckland, North Island, New Zealand
Dunedin Hospital
Dunedin, Otago, New Zealand
Middlemore Hospital
Middlemore, Otahuhu, New Zealand
Taranki Hospital
Hawera, New Zealand
Wellington Hospital
Wellington, New Zealand