A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis

• Type of Material: Article
• Authors: Coburn H. Allen, University of Texas Austin; Ran D. Goldman, University of British Columbia; Seema Bhatt, Cincinnati Children’s Hospital Medical Center; Harold Simon, Emory University; Marc H. Gorelick, Children’s Hospital of Wisconsin; Philip Spandorfer, Emory University; David M. Spiro, Oregon Health and Science University; Sharon E. Mace, Cleveland Clinic; David W. Johnson, Alberta Children’s Hospital; Eric A. Higginbotham, University of Texas Austin; Hongyan Du, Baxter Healthcare Corporation; Brendan J. Smyth, Bristol Myers Squibb; Carol R. Schermer, Baxter Healthcare Corporation; Stuart L. Goldstein, Cincinnati Children’s Hospital Medical Center
• Language: English
• Date: 2016-08-02
• Publisher: BioMed Central
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s). 2016
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1186/s12887-016-0652-4
• Title of Journal or Parent Work: BMC Pediatrics
• ISSN: 1471-2431
• Volume: 16
• Issue: 1
• Start Page: 117
• End Page: 117
• Grant/Funding Information: Baxter Healthcare Corporation funded this study.
• Keywords: DEHYDRATION; ACUTE DIARRHEA; CHILDREN; Gastroenteritis; Plasma-Lyte A; DOUBLE-BLIND CROSSOVER; Science & Technology; MANAGEMENT; Rehydration; Pediatrics; Life Sciences & Biomedicine; Balanced fluid therapy; INFUSIONS; RESUSCITATION; Dehydration; 0.9-PERCENT SALINE; Hyperchloremic metabolic acidosis; UNITED-STATES; INTRAVENOUS REHYDRATION
• Research Categories: Health Sciences, Pharmacology; Health Sciences, Medicine and Surgery

Abstract

Background: 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). Methods: 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. Results: 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). Conclusion: 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. Trial registration:NCT#01234883(Registration Date: November 3, 2010).