Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol
Introduction 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...
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BMJ Publishing Group
2025-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/7/e101215.full |
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| author | Peter Jones Gerben Keijzers John F Fraser Rinaldo Bellomo Paul Young Glenn Arendts Diana Egerton-Warburton Alisa Higgins Anthony Delaney Stephen P J Macdonald Sandra L Peake Daniel Fatovich Patricia Williams Belinda D Howe Jonathon Burcham Elissa Milford Andrew Alexander Udy |
| author_facet | Peter Jones Gerben Keijzers John F Fraser Rinaldo Bellomo Paul Young Glenn Arendts Diana Egerton-Warburton Alisa Higgins Anthony Delaney Stephen P J Macdonald Sandra L Peake Daniel Fatovich Patricia Williams Belinda D Howe Jonathon Burcham Elissa Milford Andrew Alexander Udy |
| author_sort | Peter Jones |
| collection | DOAJ |
| description | Introduction 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 |
| format | Article |
| id | doaj-art-766cb2ad1601400d99f26ba3598d68ae |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-766cb2ad1601400d99f26ba3598d68ae2025-08-20T03:12:31ZengBMJ Publishing GroupBMJ Open2044-60552025-07-0115710.1136/bmjopen-2025-101215Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocolPeter Jones0Gerben Keijzers1John F Fraser2Rinaldo Bellomo3Paul Young4Glenn Arendts5Diana Egerton-Warburton6Alisa Higgins7Anthony Delaney8Stephen P J Macdonald9Sandra L Peake10Daniel Fatovich11Patricia Williams12Belinda D Howe13Jonathon Burcham14Elissa Milford15Andrew Alexander Udy16Adult Emergency, Auckland District Health Board, Auckland, New ZealandSchool of Medicine, Griffith University, Southport, Queensland, AustraliaCritical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Queensland, AustraliaDepartment of Intensive Care, Austin Hospital, Melbourne, Victoria, AustraliaWellington Hospital, Wellington, New ZealandMedical School, The University of Western Australia, Crawley, Western Australia, AustraliaEmergency Department, Monash Medical Centre Clayton, Clayton, Victoria, AustraliaANZIC Research Centre, Monash University, Melbourne, Victoria, AustraliaThe George Institute for Global Health, Sydney, New South Wales, AustraliaCentre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Western Australia, AustraliaANZIC Research Centre, Monash University, Melbourne, Victoria, AustraliaCentre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Western Australia, AustraliaANZIC Research Centre, Monash University, Melbourne, Victoria, AustraliaANZIC Research Centre, Monash University, Melbourne, Victoria, AustraliaEmergency Department, Royal Perth Hospital, Perth, Western Australia, AustraliaIntensive Care Unit, Royal Brisbane and Women’s Hospital, Herston, Queensland, AustraliaANZIC-RC, Monash University Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, AustraliaIntroduction 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 NCT04569942https://bmjopen.bmj.com/content/15/7/e101215.full |
| spellingShingle | Peter Jones Gerben Keijzers John F Fraser Rinaldo Bellomo Paul Young Glenn Arendts Diana Egerton-Warburton Alisa Higgins Anthony Delaney Stephen P J Macdonald Sandra L Peake Daniel Fatovich Patricia Williams Belinda D Howe Jonathon Burcham Elissa Milford Andrew Alexander Udy Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol BMJ Open |
| title | Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol |
| title_full | Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol |
| title_fullStr | Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol |
| title_full_unstemmed | Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol |
| title_short | Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol |
| title_sort | australasian resuscitation in sepsis evaluation fluid or vasopressors in emergency department sepsis arise fluids trial study protocol |
| url | https://bmjopen.bmj.com/content/15/7/e101215.full |
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