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

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.

NCT Number	NCT04569942
Lead Sponsor	Australian and New Zealand Intensive Care Research Centre
Conditions	Shock, Septic
Enrollment	1,000 participants
Start Date	2021-10-26
Primary Completion	2026-02-01 (estimated)
Study Completion	2026-11-03 (estimated)
Updated on ClinicalTrials.gov	2026-03-17