ANZICS CTG Endorsed Study

ARISE FLUIDS

Australasian Resuscitation in Sepsis Evaluation: Fluids

Study Description

The Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis (ARISE FLUIDS).

We propose a pivotal multicentre, randomised clinical trial comparing a strategy of intravenous (IV) fluid sparing resuscitation with early introduction of vasopressors to the current recommended practice of a larger volume of IV fluid and later vasopressors in patients presenting to the Emergency Department (ED) with septic shock: The Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis (ARISE FLUIDS).

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. Current standard care of patients with septic shock includes the initial administration of a large volume of intravenous fluid, with vasopressor medication reserved for those with persistent hypotension. Recent evidence suggests this approach may be associated with harm, and a fluid-sparing strategy with earlier introduction of vasopressors may be better.

Building on the success of the ARISE trial and the REFRESH pilot study, we propose to randomise patients presenting to the ED with sepsis, a lactate >2mmol/L and hypotension (SBP<90mmHg or MAP <65mmHg) after receiving 1000ml of IV fluid, with antibiotics commenced to receive either a ‘vasopressor first’ strategy with sparing use of IV fluids, or current standard ‘fluid first’ management with later introduction of vasopressors. Allocation will be concealed until randomisation and the primary outcome (days alive and out of hospital at 90-day) robust. We will randomise 1000 patients, a sample size that will allow us to detect a clinically important reduction primary outcome. Given the high mortality rate of sepsis, this may lead to hundreds of lives saved per year in our country and thousands worldwide. A study aimed at resolving the uncertainty about fluid and vasopressor use in patients with septic shock Australia is, therefore, of the highest priority.

Management Committee

Sandra Peake, Stephen MacDonald, Glenn Arendts, Rinaldo Bellomo, Jonathon Burcham, Anthony Delaney, Diana Egerton-Warburton, Daniel Fatovich, John Fraser, Lisa Higgins, Peter Jones, Gerben Keijzers, Katya May, Elissa Milford, Leana Stendell, Andrew Udy, Korina Valentine, Julian Williams,Trish Williams, Belinda Howe

Administering Institution

Monash University

Sample Size

1000 patients

Funding 

MRFF, NZ HRC

Reference

CTG1718-04, NCT04569942

Contact

Belinda Howe email