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Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis

Study acronym: ARISE FLUIDS
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv11
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 19 to 50
    • Primary completion date: Oct 31, 2025 to Feb 1, 2026
    • Study completion date: Dec 31, 2026 to Nov 3, 2026
    v10
  3. Study sites: 17 to 19v9
  4. Primary completion date: Dec 31, 2024 to Oct 31, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    v8
  5. Re-verified, no change to tracked fieldsv7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 6 to 17v6
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: May 1, 2024 to Dec 31, 2024
    • Study completion date: Feb 1, 2025 to Dec 31, 2025
    • Start date changed from estimate of Sep 1, 2021 to Oct 26, 2021
    • Study sites revised (6)
  3. Start date: May 1, 2021 to Sep 1, 2021v4
  4. Start date: Feb 1, 2021 to May 1, 2021v3
  5. Study sites: 4 to 6
    • Eligibility criteria shortened, about 48 words
    • Secondary endpoints: 6 to 8
    • Study description expanded, about 26 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04569942
Lead Sponsor Australian and New Zealand Intensive Care Research Centre
Conditions
(from sponsor)		 Shock, Septic
Related terms Shock, Septic
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov