Australasian Resuscitation in Sepsis Evaluation: FLUid or vasopressors in emergency Department Sepsis (ARISE FLUIDS) trial: Study protocol

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dc.contributor.authorHowe, B.D.
dc.contributor.authorMacDonald, S.P.J.
dc.contributor.authorArendts, G.
dc.contributor.authorBellomo, R.
dc.contributor.authorBurcham, J.
dc.contributor.authorDelaney, A.
dc.contributor.authorEgerton-Warburton, D.
dc.contributor.authorFatovich, D.
dc.contributor.authorFraser, J.F.
dc.contributor.authorHiggins, A.
dc.contributor.authorJones, P.
dc.contributor.authorKeijzers, G.
dc.contributor.authorMilford, E.
dc.contributor.authorUdy, A.A.
dc.contributor.authorWilliams, P.
dc.contributor.authorYoung, P.
dc.contributor.authorPeake, S.L.
dc.date.issued2025
dc.description.abstractIntroduction: International consensus guidelines support the initial administration of 30 mL/kg of intravenous fluids for haemodynamic resuscitation of newly diagnosed septic shock. Practice variation exists between the volume of fluids administered and timing of vasopressor commencement. The optimal approach in patients with septic shock is uncertain. Methods and analysis: Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis is a 1000-participant multicentre, randomised, open-label, parallel group clinical trial conducted in patients with septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland. Participants are randomised (1:1) to either restricted fluids and early vasopressors or a larger initial intravenous fluid volume and later vasopressors. The primary outcome is days alive and out of hospital at day 90 postrandomisation. Secondary outcomes are all-cause mortality at day 90, time from randomisation until death (to day 90), days alive and at home at day 90 and ventilator-free, vasopressor-free and renal replacement-free days to day 28 postrandomisation and death or disability at 6-month and 12-month postrandomisation. Health-related quality of life will be assessed at day 180 and 12 months following randomisation. Ethics and dissemination: The study was approved by Northern Sydney Local Health District Human Research Ethics Committee (HREC2020/ETH02874) on 21 January 2021. Patients will be enrolled under a waiver of prior consent. The patient or next-of- kin (or equivalent according to local jurisdiction) is approached at the first available opportunity and given a trial information sheet. According to local approvals, the patient or next-of- kin chooses to either continue in the trial or opt-out/decline continued participation. Results will be disseminated in peer-reviewed journals and presented at academic conferences. Trial registration number: NCT04569942
dc.description.statementofresponsibilityBelinda D. Howe, Stephen P. J. Macdonald, Glenn Arendts, Rinaldo Bellomo, Jonathon Burcham, Anthony Delaney, Diana Egerton-Warburton, Daniel Fatovich, John F. Fraser, Alisa Higgins, Peter Jones, Gerben Keijzers, Elissa Milford, Andrew Alexander Udy, Patricia Williams, Paul Young, Sandra L. Peake
dc.identifier.citationBMJ Open, 2025; 15(7):e101215-1-e101215-8
dc.identifier.doi10.1136/bmjopen-2025-101215
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.orcidWilliams, P. [0000-0002-3948-5573]
dc.identifier.orcidPeake, S.L. [0000-0001-6682-7973]
dc.identifier.urihttps://hdl.handle.net/2440/148033
dc.language.isoen
dc.publisherBMJ Publishing Group
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/1200084
dc.rights© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group. Open access. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ licenses/by/4.0/.
dc.source.urihttps://doi.org/10.1136/bmjopen-2025-101215
dc.subjectAustralasian; Sepsis Evaluation
dc.subject.meshHumans
dc.subject.meshSepsis
dc.subject.meshShock, Septic
dc.subject.meshVasoconstrictor Agents
dc.subject.meshFluid Therapy
dc.subject.meshResuscitation
dc.subject.meshQuality of Life
dc.subject.meshEmergency Service, Hospital
dc.subject.meshAustralia
dc.subject.meshNew Zealand
dc.subject.meshMulticenter Studies as Topic
dc.subject.meshRandomized Controlled Trials as Topic
dc.titleAustralasian Resuscitation in Sepsis Evaluation: FLUid or vasopressors in emergency Department Sepsis (ARISE FLUIDS) trial: Study protocol
dc.typeJournal article
pubs.publication-statusPublished

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