title: Overview of the study protocols and statistical analysis plan for the Saline versus Plasma-Lyte 148 for Intravenous Fluid Therapy (SPLIT) research program.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand. paul.young@ccdhb.org.nz.
authors.forename: Sumeet K
authors.initials: SK
authors.lastname: Reddy
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Young
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Richard W
authors.initials: RW
authors.lastname: Beasley
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Diane M
authors.initials: DM
authors.lastname: Mackle
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Shay P
authors.initials: SP
authors.lastname: McGuinness
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Colin J
authors.initials: CJ
authors.lastname: McArthur
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Seton J
authors.initials: SJ
authors.lastname: Henderson
authors.affiliation: Department of Anaesthesia, Austin Hospital, Melbourne, VIC, Australia.
authors.forename: Laurence
authors.initials: L
authors.lastname: Weinberg
authors.affiliation: Intensive Care Unit, The Western Hospital, Melbourne, VIC, Australia.
authors.forename: Craig J
authors.initials: CJ
authors.lastname: French
authors.affiliation: Intensive Care Unit, Geelong Hospital, Geelong, VIC, Australia.
authors.forename: Neil R
authors.initials: NR
authors.lastname: Orford
authors.affiliation: Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Bailey
authors.affiliation: Intensive Care Unit, Wellington Hospital, Wellington, New Zealand.
authors.forename: Rinaldo
authors.initials: R
authors.lastname: Bellomo
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology; D002985:Clinical Protocols; D016000:Cluster Analysis; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005440:Fluid Therapy / Q000379:methods*; D005942:Gluconates / Q000008:administration & dosage; D006801:Humans; D015636:Magnesium Chloride / Q000008:administration & dosage; D011189:Potassium Chloride / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D019346:Sodium Acetate / Q000008:administration & dosage; D012965:Sodium Chloride / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D005942:Gluconates; C012499:Plasma-lyte 148; D015636:Magnesium Chloride; D012965:Sodium Chloride; D019346:Sodium Acetate; D011189:Potassium Chloride