title: A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis.
abstract: Compare the efficacy and safety of Plasma-Lyte A (PLA) versus 0.9 % sodium chloride (NaCl) intravenous (IV) fluid replacement in children with moderate to severe dehydration secondary to acute gastroenteritis (AGE).
  
  
  
  Prospective, randomized, double-blind study conducted at eight pediatric emergency departments (EDs) in the US and Canada (NCT#01234883). The primary outcome measure was serum bicarbonate level at 4 h. Secondary outcomes included safety and tolerability. The hypothesis was that PLA would be superior to 0.9 % NaCl in improvement of 4-h bicarbonate. Patients (n = 100) aged ≥6 months to <11 years with AGE-induced moderate-to-severe dehydration were enrolled. Patients with a baseline bicarbonate level ≤22 mEq/L formed the modified intent to treat (mITT) group.
  
  
  
  At baseline, the treatment groups were comparable except that the PLA group was older. At hour 4, the PLA group had greater increases in serum bicarbonate from baseline than did the 0.9 % NaCl group (mean ± SD at 4 h: 18 ± 3.74 vs 18.0 ± 3.67; change from baseline of 1.6 and 0.0, respectively; P = .004). Both treatment groups received similar fluid volumes. The PLA group had less abdominal pain and better dehydration scores at hour 2 (both P = .03) but not at hour 4 (P = 0.15 and 0.08, respectively). No patient experienced clinically relevant worsening of laboratory findings or physical examination, and hospital admission rates were similar. One patient in each treatment group developed hyponatremia. Four patients developed hyperkalemia (PLA:1, 0.9 % NaCl:3).
  
  
  
  In comparison with 0.9 % NaCl, PLA for rehydration in children with AGE was well tolerated and led to more rapid improvement in serum bicarbonate and dehydration score.
  
  
  
  NCT#01234883 (Registration Date: November 3, 2010).
authors.affiliation: Department of Pediatrics, Dell Medical School at University of Texas at Austin, 4900 Mueller Blvd, Austin, TX, 78746, USA. challen@seton.org.
authors.forename: Coburn H
authors.initials: CH
authors.lastname: Allen
authors.affiliation: Department of Pediatrics, British Columbia Children's Hospital, University of British Columbia, Vancouver, BC, Canada.
authors.forename: Ran D
authors.initials: RD
authors.lastname: Goldman
authors.affiliation: Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Seema
authors.initials: S
authors.lastname: Bhatt
authors.affiliation: Departments of Pediatrics and Emergency Medicine, Emory University/Children's Healthcare of Atlanta, Atlanta, GA, USA.
authors.forename: Harold K
authors.initials: HK
authors.lastname: Simon
authors.affiliation: Pediatric Emergency Medicine, Children's Hospital of Wisconsin, Milwaukee, WI, USA.
authors.forename: Marc H
authors.initials: MH
authors.lastname: Gorelick
authors.affiliation: Pediatric Emergency Medicine Associates, Children's Healthcare of Atlanta, Atlanta, GA, USA.
authors.forename: Philip R
authors.initials: PR
authors.lastname: Spandorfer
authors.affiliation: Pediatric Emergency Services, Oregon Health and Science University, Portland, OR, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Spiro
authors.affiliation: Department of Emergency Medicine, Cleveland Clinic, Cleveland, OH, USA.
authors.forename: Sharon E
authors.initials: SE
authors.lastname: Mace
authors.affiliation: Departments of Pediatrics, Pharmacology and Physiology, Alberta Children's Hospital, Calgary, AB, Canada.
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
authors.affiliation: Department of Pediatrics, Dell Medical School at University of Texas at Austin, 4900 Mueller Blvd, Austin, TX, 78746, USA.
authors.forename: Eric A
authors.initials: EA
authors.lastname: Higginbotham
authors.affiliation: Research and Development, Baxter Healthcare Corporation, Deerfield, IL, USA.
authors.forename: Hongyan
authors.initials: H
authors.lastname: Du
authors.affiliation: Bristol-Myers Squibb, Pennington, NJ, USA.
authors.forename: Brendan J
authors.initials: BJ
authors.lastname: Smyth
authors.affiliation: Research and Development, Baxter Healthcare Corporation, Deerfield, IL, USA.
authors.forename: Carol R
authors.initials: CR
authors.lastname: Schermer
authors.affiliation: Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Stuart L
authors.initials: SL
authors.lastname: Goldstein
mesh_terms: D001639:Bicarbonates / Q000097:blood; D002648:Child; D002675:Child, Preschool; D003681:Dehydration / Q000097:blood / Q000209:etiology / Q000628:therapy*; D004311:Double-Blind Method; D004573:Electrolytes / Q000009:adverse effects / Q000627:therapeutic use*; D005759:Gastroenteritis / Q000150:complications*; D006801:Humans; D007223:Infant; D007262:Infusions, Intravenous; D057194:Intention to Treat Analysis; D010952:Plasma Substitutes / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D015532:Rehydration Solutions / Q000009:adverse effects / Q000627:therapeutic use*; D012965:Sodium Chloride / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D001639:Bicarbonates; D004573:Electrolytes; D010952:Plasma Substitutes; D015532:Rehydration Solutions; D012965:Sodium Chloride; C048013:Plasmalyte A
keywords: Balanced fluid therapy; Dehydration; Gastroenteritis; Hyperchloremic metabolic acidosis; Plasma-Lyte A; Rehydration