ANZICS CTG Endorsed Study
The Plasma-Lyte 148® vs Saline study
PLUS is a multi-centre, blinded, randomised, controlled trial (RCT) to determine whether fluid resuscitation and therapy with a “balanced” crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation when compared with the same treatment using 0.9% sodium chloride (saline). This study will enrol 8,800 patients in approximately 50 study sites in Australia and New Zealand.
Participants will be patients expected to be treated in the Intensive Care Unit (ICU) for three days or more. They will be randomly assigned to receive either Plasma-Lyte 148® or saline for all resuscitation episodes and for all compatible crystalloid therapy while in ICU for up to 90 days after the first episode of fluid resuscitation.
PLUS is a pivotal trial that will provide an accurate and reliable estimate of the comparative risks versus benefit of Plasma-Lyte 148® versus 0.9% sodium chloride. As the only definitive trial comparing normal saline with a balanced solution, PLUS will influence clinical practice guidelines and clinical practice worldwide and will affect the health of millions of acute and critically ill people.
Simon Finfer (Chair), Rinaldo Bellomo, Martin Gallagher, David Gattas, Naomi Hammond, Diane Mackle, Sharon Micallef (Project Manager), John Myburgh, Manoj Saxena, Colman Taylor, Paul Young.
The George Institute for Global Health / University of NSW, Sydney
Baxter Healthcare (provision of fluids no influence on study)
NHMRC – Project Grant – $5,984,818
NZHRC – Project Grant – NZ$1,385,250
Project Status as of June 2018
Current recruitment 880/8800. 49/50 sites initiated. 45/50 sites actively screening/recruiting. HREC approvals received for all sites with governance pending for one site. All other regulatory approvals in place. Rework process for study fluid continues (Baxter). PLUS DSMC recommendation for PLUS to continue post review of SMART study results (March 2018).
CTG ID No 1415-03
ClinicalTrials.gov Registry Identifier: NCT02721654