澳大利亚脓毒症复苏评估：急诊科脓毒症中使用液体或血管加压药（ARISE FLUIDS）试验：研究方案
Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol.
作者信息
Howe Belinda D, Macdonald Stephen P J, Arendts Glenn, Bellomo Rinaldo, Burcham Jonathon, Delaney Anthony, Egerton-Warburton Diana, Fatovich Daniel, Fraser John F, Higgins Alisa, Jones Peter, Keijzers Gerben, Milford Elissa, Udy Andrew Alexander, Williams Patricia, Young Paul, Peake Sandra L
机构信息
ANZIC Research Centre, Monash University, Melbourne, Victoria, Australia
Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research, Perth, Western Australia, Australia.
出版信息
BMJ Open. 2025 Jul 20;15(7):e101215. doi: 10.1136/bmjopen-2025-101215.
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.
引言
国际共识指南支持初始给予30毫升/千克静脉输液，用于新诊断的感染性休克的血流动力学复苏。在输液量和血管活性药物开始使用的时机方面存在实践差异。感染性休克患者的最佳治疗方法尚不确定。
方法与分析
澳大利亚和新西兰脓毒症复苏评估：急诊科脓毒症中的液体或血管活性药物（Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis，ARISE）是一项纳入1000名参与者的多中心、随机、开放标签、平行组临床试验，研究对象为在澳大利亚、新西兰和爱尔兰参与研究地点的急诊科就诊的感染性休克患者。参与者被随机分配（1:1）至限制性液体和早期血管活性药物组或初始静脉输液量较大和晚期血管活性药物组。主要结局是随机分组后90天时存活并出院的天数。次要结局包括90天时的全因死亡率、从随机分组到死亡（至90天）的时间、90天时存活并在家中的天数、随机分组后至第28天无呼吸机、无血管活性药物和无肾脏替代治疗的天数，以及随机分组后6个月和12个月时的死亡或残疾情况。将在随机分组后180天和12个月评估健康相关生活质量。
伦理与传播
该研究于2021年1月21日获得北悉尼地方卫生区人类研究伦理委员会（HREC2020/ETH02874）批准。患者将在豁免事先同意的情况下入组。在第一个合适的机会与患者或其近亲（或根据当地司法管辖区的同等人员）联系，并提供试验信息表。根据当地批准情况，患者或其近亲选择继续参加试验或退出/拒绝继续参与。研究结果将在同行评审期刊上发表，并在学术会议上展示。
试验注册号
NCT04569942。
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