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Title: Overview of the study protocols and statistical analysis plan for the Saline versus Plasma-Lyte 148 for Intravenous Fluid Therapy (SPLIT) research program.
Austin Authors: Reddy, Sumeet K;Young, Paul J;Beasley, Richard W;Mackle, Diane M;McGuinness, Shay P;McArthur, Colin J;Henderson, Seton J;Weinberg, Laurence ;French, Craig J;Orford, Neil R;Bailey, Michael J;Bellomo, Rinaldo 
Affiliation: Intensive Care Unit, Geelong Hospital, Geelong, Victoria, Australia
Department of Anaesthesia, Austin Hospital, Melbourne, Victoria, Australia
Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia
Intensive Care Unit, The Western Hospital, Melbourne, Victoria, Australia
Medical Research Institute of New Zealand, Wellington, New Zealand.
Medical Research Institute of New Zealand, Wellington, New Zealand.
Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
Issue Date: 1-Mar-2015
Publication information: Critical Care and Resuscitation; 17(1): 29-36
Abstract: 0.9% 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.To 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.The 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.The 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.
Gov't Doc #: 25702759
Type: Journal Article
Subjects: Acute Kidney Injury.etiology
Clinical Protocols
Cluster Analysis
Cross-Over Studies
Double-Blind Method
Fluid Therapy.methods
Gluconates.administration & dosage
Magnesium Chloride.administration & dosage
Potassium Chloride.administration & dosage
Randomized Controlled Trials as Topic
Sodium Acetate.administration & dosage
Sodium Chloride.administration & dosage.adverse effects
Appears in Collections:Journal articles

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