title: Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial.
abstract: Saline is the intravenous fluid most commonly administered to critically ill adults, but it may be associated with acute kidney injury and death. Whether use of balanced crystalloids rather than saline affects patient outcomes remains unknown.
  
  
  
  To pilot a cluster-randomized, multiple-crossover trial using software tools within the electronic health record to compare saline to balanced crystalloids.
  
  
  
  This was a cluster-randomized, multiple-crossover trial among 974 adults admitted to a tertiary medical intensive care unit from February 3, 2015 to May 31, 2015. The intravenous crystalloid used in the unit alternated monthly between saline (0.9% sodium chloride) and balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A). Enrollment, fluid delivery, and data collection were performed using software tools within the electronic health record. The primary outcome was the difference between study groups in the proportion of isotonic crystalloid administered that was saline. The secondary outcome was major adverse kidney events within 30 days (MAKE30), a composite of death, dialysis, or persistent renal dysfunction.
  
  
  
  Patients assigned to saline (n = 454) and balanced crystalloids (n = 520) were similar at baseline and received similar volumes of crystalloid by 30 days (median [interquartile range]: 1,424 ml [500-3,377] vs. 1,617 ml [500-3,628]; P = 0.40). Saline made up a larger proportion of the isotonic crystalloid given in the saline group than in the balanced crystalloid group (91% vs. 21%; P < 0.001). MAKE30 did not differ between groups (24.7% vs. 24.6%; P = 0.98).
  
  
  
  An electronic health record-embedded, cluster-randomized, multiple-crossover trial comparing saline with balanced crystalloids can produce well-balanced study groups and separation in crystalloid receipt. Clinical trial registered with www.clinicaltrials.gov (NCT 02345486).
authors.affiliation: 1 Division of Allergy, Pulmonary, and Critical Care Medicine.
authors.forename: Matthew W
authors.identifier: 0000-0002-7664-8263
authors.initials: MW
authors.lastname: Semler
authors.affiliation: 2 Department of Anesthesiology.|3 Department of Biomedical Informatics.
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Wanderer
authors.affiliation: 2 Department of Anesthesiology.|3 Department of Biomedical Informatics.
authors.forename: Jesse M
authors.initials: JM
authors.lastname: Ehrenfeld
authors.affiliation: 4 Department of Pharmaceutical Services.
authors.forename: Joanna L
authors.initials: JL
authors.lastname: Stollings
authors.affiliation: 5 Department of Emergency Medicine.
authors.forename: Wesley H
authors.initials: WH
authors.lastname: Self
authors.affiliation: 6 Vanderbilt Center for Kidney Disease and Integrated Program for AKI, Division of Nephrology and Hypertension, and.
authors.forename: Edward D
authors.initials: ED
authors.lastname: Siew
authors.affiliation: 7 Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Li
authors.initials: L
authors.lastname: Wang
authors.affiliation: 7 Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Daniel W
authors.initials: DW
authors.lastname: Byrne
authors.affiliation: 2 Department of Anesthesiology.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Shaw
authors.affiliation: 1 Division of Allergy, Pulmonary, and Critical Care Medicine.
authors.forename: Gordon R
authors.initials: GR
authors.lastname: Bernard
authors.affiliation: 1 Division of Allergy, Pulmonary, and Critical Care Medicine.
authors.forename: Todd W
authors.initials: TW
authors.lastname: Rice
mesh_terms: D000328:Adult; D000368:Aged; D016000:Cluster Analysis; D003422:Critical Care / Q000379:methods*; D016638:Critical Illness / Q000628:therapy; D018592:Cross-Over Studies; D000077324:Crystalloid Solutions; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D007362:Intensive Care Units; D007552:Isotonic Solutions / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012965:Sodium Chloride / Q000627:therapeutic use*
chemical_list: D000077324:Crystalloid Solutions; D007552:Isotonic Solutions; D012965:Sodium Chloride
keywords: acute kidney injury; critical illness; crystalloid; intravenous fluid; saline