• Crit Care Resusc · Mar 2015

    Overview of the study protocols and statistical analysis plan for the Saline versus Plasma-Lyte 148 for Intravenous Fluid Therapy (SPLIT) research program.

    • Sumeet K Reddy, Paul J Young, Richard W Beasley, Diane M Mackle, Shay P McGuinness, Colin J McArthur, Seton J Henderson, Laurence Weinberg, Craig J French, Neil R Orford, Michael J Bailey, and Rinaldo Bellomo.
    • Medical Research Institute of New Zealand, Wellington, New Zealand. paul.young@ccdhb.org.nz.
    • Crit Care Resusc. 2015 Mar 1;17(1):29-36.

    Background0.9% saline is the most commonly used intravenous (IV) fluid in the world but recent data raise the possibility that, compared with buffered crystalloid fluids such as Plasma-Lyte 148, the administration of 0.9% saline might increase the risk of developing acute kidney injury.ObjectiveTo provide an overview of the study protocols and statistical analysis plan for the six studies making up the (0.9% Saline v Plasma-Lyte 148 for Intravenous Fluid Therapy (SPLIT) research program.MethodsThe SPLIT study consists of six integrated clinical trials, including a double-blind, cluster, randomised, double-crossover study in intensive care unit patients, incorporating two nested studies within it; an open-label, before-and-after study in emergency department (ED) patients; a single-centre, double-blind, crossover trial in major surgical patients; and a randomised, double-blind study in ICU patients. All studies focus on biochemical and renal outcomes but will also provide preliminary data on patient-centred outcomes including inhospital mortality and requirements for dialysis.Results And ConclusionThe SPLIT study program will provide preliminary data on the comparative effectiveness of using 0.9% saline v Plasma-Lyte 148 for IV fluid therapy in ED, surgical and ICU patients.

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