02995nas a2200517 4500000000100000008004100001653001100042653001900053653001700072653001400089653001600103653002500119653002000144653003000164653001500194653002100209653001400230653001800244653002800262653001800290653002700308653001500335653002000350653002300370653002300393653001900416653002000435653002300455100001700478700001700495700001700512700002000529700001800549700001700567700001700584700001400601700001800615700002000633700001700653700001500670245015900685300001200844490000700856520160000863022001402463 2017 d10aHumans10aLength of Stay10aTime Factors10aAustralia10aNew Zealand10aIntensive Care Units10aQuality of Life10aRenal Replacement Therapy10aCreatinine10aCritical Illness10aMortality10aFluid Therapy10aRespiration, Artificial10aResuscitation10aVasoconstrictor Agents10aGluconates10aHealth Services10aMagnesium Chloride10aPotassium Chloride10aSodium Acetate10aSodium Chloride10aVasodilator Agents1 aGlass Parisa1 aFinfer Simon1 aGallagher M.1 aBellomo Rinaldo1 aHammond Naomi1 aMackle Diane1 aSaxena Manoj1 aMyburgh J1 aTaylor Colman1 aMicallef Sharon1 aGattas David1 aYoung Paul00aThe Plasma-Lyte 148 v Saline (PLUS) study protocol: a multicentre, randomised controlled trial of the effect of intensive care fluid therapy on mortality. a239-2460 v193 a
BACKGROUND: 0.9% sodium chloride (saline) is the most commonly administered resuscitation fluid on a global basis but emerging evidence suggests that its high chloride content may have important adverse effects.
OBJECTIVE: To describe the study protocol for the Plasma- Lyte 148 v Saline study, which will test the hypothesis that in critically ill adult patients the use of Plasma-Lyte 148 (a buffered crystalloid solution) for fluid therapy results in different 90-day all-cause mortality when compared with saline.
DESIGN AND SETTING: We will conduct this multicentre, blinded, randomised controlled trial in approximately 50 intensive care units in Australia and New Zealand. We will randomly assign 8800 patients to either Plasma-Lyte 148 or saline for all resuscitation fluid, maintenance fluid and compatible drug dilution therapy while in the ICU for up to 90 days after randomisation.
OUTCOME MEASURES: The primary outcome is 90-day all-cause mortality; secondary outcomes include mean and peak creatinine concentration, incidence of renal replacement therapy, incidence and duration of vasoactive drug treatment, duration of mechanical ventilation, ICU and hospital length of stay, and quality of life and health services use at 6 months.
RESULTS AND CONCLUSIONS: The PLUS study will provide high-quality data on the comparative safety and efficacy of Plasma-Lyte 148 compared with saline for resuscitation and compatible crystalloid fluid therapy in critically ill adult patients.
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