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

Summary

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.

Timeline

Start

2021-10-26

Primary completion

2026-02-01

Completion

2026-11-03

Publications

• ARISE FLUIDS Investigators, the ANZICS Clinical Trials Group, and the ACEM Clinical Trials Network; Peake SL, Macdonald SPJ, Howe BD, Milford E, Jones P, Arendts G, Bailey M, Burcham J, Delaney A, Egerton-Warburton D, Fatovich D, Fraser JF, Higgins AM, Keijzers G, Udy AA, Williams P, Young PJ, Bellomo R. Vasopressors or Fluids in Early Septic Shock. N Engl J Med. 2026 Jun 11. doi: 10.1056/NEJMoa2516225. Online ahead of print.
• Howe BD, Macdonald SPJ, Arendts G, Bellomo R, Burcham J, Delaney A, Egerton-Warburton D, Fatovich D, Fraser JF, Higgins A, Jones P, Keijzers G, Milford E, Udy AA, Williams P, Young P, Peake SL. Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial: study protocol. BMJ Open. 2025 Jul 20;15(7):e101215. doi: 10.1136/bmjopen-2025-101215.

Drugs

Indications

No indication recorded.