Plasma-Lyte 148® versUs Saline Study

Phase 4 Completed 5037 enrolled The George Institute Australian and New Zealand Intensive Care Society Clinical Trials Group · collab Baxter Healthcare Corporation · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of PLUS is to conduct 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)

Timeline

Start: 2017-09-01
Primary completion: 2021-03-30
Completion: 2021-06-30

Publications

Finfer S, Micallef S, Hammond N, Navarra L, Bellomo R, Billot L, Delaney A, Gallagher M, Gattas D, Li Q, Mackle D, Mysore J, Saxena M, Taylor C, Young P, Myburgh J; PLUS Study Investigators and the Australian New Zealand Intensive Care Society Clinical Trials Group. Balanced Multielectrolyte Solution versus Saline in Critically Ill Adults. N Engl J Med. 2022 Mar 3;386(9):815-826. doi: 10.1056/NEJMoa2114464. Epub 2022 Jan 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Plasmalyte	Other / unclassified	—	Intravenous
Comparator	sodium chloride	Unknown	—	Intravenous

Indications

No indication recorded.