ANZICS CTG Endorsed Study
Australasian Resuscitation in Sepsis Evaluation: Fluids
The Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis (ARISE FLUIDS).
The ARISE FLUIDS study is a multicentre, randomised, parallel group clinical trial of a restricted fluids and early vasopressor strategy compared to a larger initial intravenous (IV) fluid volume and later vasopressors for the haemodynamic resuscitation of patients with septic shock presenting to the emergency department (ED). It will be conducted in hospitals in Australia and New Zealand with 1000 patients recruited over a 3-year period.
Sepsis is a major public health issue, recognised as a Global Health Priority by the World Health Organisation. Sepsis affects over 18,000 patients per year in Australia, with a burden of death more than 3 times the annual national road toll.
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 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.
Building on the success of the ARISE trial and the REFRESH pilot study, the trial proposes to randomise patients presenting to the ED with suspected sepsis, a lactate >2mmol/L, hypotension (SBP <90 mm Hg or MAP <65 mm Hg) after receiving 1000ml of IV fluid and first dose of IV antimicrobial commenced. They will be allocated to receive either the ‘vasopressor’ strategy with sparing use of IV fluids and early vasopressors, or ‘fluids’ strategy with a larger initial IV fluid volume and later introduction of vasopressors, if required.
The primary outcome is days alive and out of hospital at day 90 (DAOH-D90) post-randomisation.
Septic shock is associated with significant mortality and reduced quality of life in survivors. The primary outcome of days alive and out of hospital to day 90 (DAOH-D90) is a patient-centred outcome measure that will capture both death and morbidity.
The ARISE FLUIDS trial will address an important gap in the evidence base regarding the early haemodynamic management of patients with septic shock, provide clear guidance for bedside clinicians and optimise important patient-centred outcomes.
Sandra Peake and Stephen MacDonald (Co-Chief Investigators), Anthony Delaney, Lisa Higgins, Belinda Howe, Gerben Keijzers, Peter Jones, Katya May, Andrew Udy, Trish Williams, Glenn Arendts, Rinaldo Bellomo, Jonathan Burcham, Diana Egerton-Warburt, Daniel Fatovich, John Fraser, Elissa Milford, Leana Stendall, Korina Valentine and Paul Young.
This study is funded by a grant from the MRFF of Australia.
Recruitment commenced October 2021
Belinda Howe email