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

UBC Faculty Research and Publications

A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis Allen, Coburn H; Goldman, Ran D; Bhatt, Seema; Simon, Harold K; Gorelick, Marc H; Spandorfer, Philip R; Spiro, David M; Mace, Sharon E; Johnson, David W; Higginbotham, Eric A; et al.

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).

Item Metadata

Title	A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis
Creator	Allen, Coburn H; Goldman, Ran D; Bhatt, Seema; Simon, Harold K; Gorelick, Marc H; Spandorfer, Philip R; Spiro, David M; Mace, Sharon E; Johnson, David W; Higginbotham, Eric A; Du, Hongyan; Smyth, Brendan J; Schermer, Carol R; Goldstein, Stuart L
Contributor	Children's Hospital (Vancouver, B.C.)
Publisher	BioMed Central
Date Issued	2016-08-02
Description	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).
Subject	Balanced fluid therapy; Dehydration; Hyperchloremic metabolic acidosis; Plasma-Lyte A; Rehydration; Gastroenteritis
Genre	Article
Type	Text
Language	eng
Date Available	2018-05-15
Provider	Vancouver : University of British Columbia Library
Rights	Attribution 4.0 International (CC BY 4.0)
DOI	10.14288/1.0366843
URI	http://hdl.handle.net/2429/65903
Affiliation	Medicine, Faculty of; Other UBC; Non UBC; Pediatrics, Department of
Citation	BMC Pediatrics. 2016 Aug 02;16(1):117
Publisher DOI	10.1186/s12887-016-0652-4
Peer Review Status	Reviewed
Scholarly Level	Faculty
Copyright Holder	The Author(s).
Rights URI	http://creativecommons.org/licenses/by/4.0/
Aggregated Source Repository	DSpace

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