title: A protocol for the 0.9% saline versus Plasma-Lyte 148 for intensive care fluid therapy (SPLIT) study.
abstract: BACKGROUND
  0.9% saline is the most commonly used intravenous (IV) fluid in the world. However, recent data raise the possibility that, compared with buffered crystalloid fluids such as Plasma-Lyte 148, the administration of 0.9% saline to intensive care unit patients might increase their risk of acute kidney injury (AKI).
  
  
  OBJECTIVE
  To describe the protocol for the 0.9% Saline v Plasma-Lyte 148 for ICU Fluid Therapy (SPLIT) study.
  
  
  METHODS
  This is a multicentre, cluster-randomised, double crossover feasibility study to be conducted in four New Zealand tertiary ICUs over a 28-week period and will enroll about 2300 participants. All ICU patients who need crystalloid IV fluid therapy (except those with established renal failure needing dialysis and those admitted to the ICU for palliative care) will be enrolled. Participating ICUs will be randomly assigned to 0.9% saline or Plasma-Lyte 148 as the routine crystalloid IV fluid, in a blinded fashion, in four alternating 7-week blocks.
  
  
  METHODS
  The primary outcome will be the proportion of patients who develop AKI in the ICU. Secondary outcomes will include the difference between the most recent serum creatinine level measured before study enrollment and the peak serum creatinine level in the ICU; use of renal replacement therapy; and ICU and in hospital mortality. All analyses will be conducted on an intention-to-treat basis.
  
  
  CONCLUSIONS
  The SPLIT study started on 1 April 2014 and will provide preliminary data on the comparative effectiveness of using 0.9% saline v Plasma- Lyte 148 as the routine IV fluid therapy in ICU patients.
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Sumeet K
authors.initials: SK
authors.lastname: Reddy
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: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Richard W
authors.initials: RW
authors.lastname: Beasley
authors.affiliation: Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
authors.forename: Rinaldo
authors.initials: R
authors.lastname: Bellomo
authors.affiliation: Department of Intensive Care Medicine, Christchurch Hospital, Christchurch, New Zealand.
authors.forename: Seton J
authors.initials: SJ
authors.lastname: Henderson
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Diane M
authors.initials: DM
authors.lastname: Mackle
authors.affiliation: Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.
authors.forename: Colin J
authors.initials: CJ
authors.lastname: McArthur
authors.affiliation: Department of Intensive Care Medicine, Christchurch Hospital, Christchurch, New Zealand.
authors.forename: Jan E
authors.initials: JE
authors.lastname: Mehrtens
authors.affiliation: Intensive Care Unit, St George Hospital, Sydney, NSW, Australia.
authors.forename: John A
authors.initials: JA
authors.lastname: Myburgh
authors.affiliation: Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.
authors.forename: Shay P
authors.initials: SP
authors.lastname: McGuinness
authors.affiliation: Intensive Care Unit, Wellington Regional Hospital, Wellington, New Zealand.
authors.forename: Alex J
authors.initials: AJ
authors.lastname: Psirides
authors.affiliation: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Young
mesh_terms: D058186:Acute Kidney Injury; D001783:Blood Flow Velocity; D002314:Cardioplegic Solutions / Q000627:therapeutic use*; D002985:Clinical Protocols; D003404:Creatinine / Q000097:blood; D003422:Critical Care; D018592:Cross-Over Studies; D005440:Fluid Therapy / Q000379:methods*; D005942:Gluconates / Q000627:therapeutic use; D006801:Humans; D015636:Magnesium Chloride / Q000627:therapeutic use; D011189:Potassium Chloride / Q000627:therapeutic use; D012077:Renal Artery / Q000503:physiopathology; D012107:Research Design; D019346:Sodium Acetate / Q000627:therapeutic use; D012965:Sodium Chloride / Q000627:therapeutic use
chemical_list: D002314:Cardioplegic Solutions; D005942:Gluconates; C012499:Plasma-lyte 148; D015636:Magnesium Chloride; D012965:Sodium Chloride; D019346:Sodium Acetate; D011189:Potassium Chloride; D003404:Creatinine