ARISE-FLUIDS

Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis

Aim: To compare the effect of a strategy of restricted fluids and early introduction of vasopressors to a strategy which involves a larger initial volume of IV fluid and later vasopressor administration if required, for haemodynamic resuscitation of patients with early septic shock.

Rationale: The optimal approach to haemodynamic resuscitation in patients with septic shock is uncertain. Conventional practice, supported by international consensus guidelines, is initial administration of 30 ml/kg of intravenous (IV) fluids for newly diagnosed septic shock. Emerging evidence of harm associated with excessive IV fluids has led to more recent variation in practice with some clinicians favouring smaller fluid volumes combined with early vasopressor administration to restore systemic blood pressure. The impact on clinical outcomes among patients with septic shock presenting to emergency departments in Australia and New Zealand is unknown. This study will provide robust evidence for clinicians regarding the optimal approach to early haemodynamic resuscitation in septic shock to improve patient-centred clinical outcomes.

Study Progress: The study has ethical approval and started recruitment at vanguard sites in October 2021. A target of 1,000 participants will be enrolled at sites in Australia, New Zealand and Ireland.

Keep up to date with our progress and study updates on Twitter and Facebook.

Twitter: @ARISEFluidsRCT https://twitter.com/ARISEFluidsRct

Facebook:  @ARISEFluidsRCT https://fb.me/ARISEFluidsRCT

Further information and Data Entry/CRF: https://www.arisefluids.org

Trial Registration: ClinicalTrials.gov ID: NCT04569942

Endorsement: The ARISE-FLUIDS study is endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS-CTG) and the Australasian College for Emergency Medicine Clinical Trials Network (ACEM CTN).

Funding: The ARISE-FLUIDS Study is funded by the NHMRC of Australia’s Medical Research Future Fund (MRFF) Rare Cancers, Rare Disease and Unmet Need grant scheme (MRF1200084).

Documents:

ARISE-FLUIDS comment on CLOVERS trial.3FEB2023 (Uploaded 6 Feb 2023, 34KB)

Contact: For further information about this study, please contact the ANZIC-RC ARISE-FLUIDS Project Manager, Belinda Howe by email. The Lead Investigators are Professor Sandra Peake and A/Professor Stephen Macdonald.