Naomi E Hammond1, Rinaldo Bellomo2, Martin Gallagher3, David Gattas4, Parisa Glass1, Diane Mackle5, Sharon Micallef1, John Myburgh1, Manoj Saxena1, Colman Taylor1, Paul Young6, Simon Finfer1. 1. Critical Care and Trauma Division, The George Institute for Global Health, Sydney, NSW, Australia. 2. Intensive Care Unit, Austin Hospital, Melbourne, VIC, Australia. 3. Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia. 4. Sydney Medical School, University of Sydney, Sydney, NSW, Australia. 5. Medical Research Institute of New Zealand, Wellington, New Zealand. 6. Intensive Care Unit, Royal Prince Alfred Hospital, Sydney, NSW, Australia.
Abstract
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 bufferedcrystalloid 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 eitherPlasma-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.
RCT Entities:
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.
Authors: Wesley H Self; Matthew W Semler; Jonathan P Wanderer; Li Wang; Daniel W Byrne; Sean P Collins; Corey M Slovis; Christopher J Lindsell; Jesse M Ehrenfeld; Edward D Siew; Andrew D Shaw; Gordon R Bernard; Todd W Rice Journal: N Engl J Med Date: 2018-02-27 Impact factor: 91.245
Authors: Anders Perner; Maurizio Cecconi; Maria Cronhjort; Michael Darmon; Stephan M Jakob; Ville Pettilä; Iwan C C van der Horst Journal: Intensive Care Med Date: 2018-04-25 Impact factor: 17.440
Authors: Yazan Z M Zayed; Ahmed M Y Aburahma; Mahmoud O Barbarawi; Kewan Hamid; Momen R N Banifadel; Laith Rashdan; Ghassan I Bachuwa Journal: J Intensive Care Date: 2018-08-17