ARISE Fluids

ANZICS CTG Endorsed Study


Australasian Resuscitation in Sepsis Evaluation: Fluids

Study Description

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) after receiving 1000ml of IV fluid, 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 and the primary outcome (90-day mortality) robust. We will randomise 3000 patients, a sample size that will allow us to detect a clinically important reduction in mortality. 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 (Chair), Stephen MacDonald, Glenn Arendts, Rinaldo Bellomo, Jonathon Burcham, Anthony Delaney, Diana Egerton-Warburton, Daniel Fatovich, John Fraser, Lisa Higgins, Belinda Howe, Peter Jones, Gerben Keijzers, Katya May, Elissa Milford, Leana Stendell, David Taylor, Andrew Udy, Korina Valentine, Julian Williams, Trish Williams

Administering Institution

Monash University



Sample Size

1000 patients


Medical Research Future Fund grant – Successful Awarded $2,335,540

Project Status 

ETHICS, RGO & CONTRACTS                                                                                                                                        The trial has ethics approval in Australia under NMA with several sites having SSA approval and contract sign off. The trial has ethics approval in New Zealand with site localities to be progressed.                                                      DSMC                                                                                                                                                                                        The Data Safety Monitoring Committee is in place with meeting held and charter and tables finalised and SAE processes agreed upon.                                                                                                                                                                SITE RECRUITMENT                                                                                                                                                            Currently in Australia, 45 sites have been approved/added to the ethics with another 6 sites in discussion.                 New Zealand has 9 sites approved. This brings the total sites to approximately 54 currently with a good mix of established and new to research sites.                                                                                                                                             CRF & WEBSITE                                                                                                                                                                 The CRF is completed and we await the website staging production. The only requirement for study start which we await is the website. This is anticipated (hoped) to be ready by mid-late August.




Andrew Udy (email)