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

Coburn H Allen,Stuart L Goldstein,Marc H Gorelick,Brendan J Smyth,Sharon E Mace,David M Spiro,Carol R Schermer,David W Johnson,Hongyan Du,Harold K Simon,Philip R Spandorfer,Eric A Higginbotham,Seema Bhatt,Ran D Goldman

doi:10.1186/s12887-016-0652-4

Abstract

BackgroundCompare 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).MethodsProspective, 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.ResultsAt 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).ConclusionIn 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 registrationNCT#01234883 (Registration Date: November 3, 2010).Electronic supplementary materialThe online version of this article (doi:10.1186/s12887-016-0652-4) contains supplementary material, which is available to authorized users.

Highlights

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)
0.9 % Sodium chloride (NaCl), which contains a supraphysiologic chloride concentration, can induce hyperchloremic metabolic acidosis (HCA), which can exacerbate the low serum bicarbonate levels often associated with diarrhea and poor perfusion from dehydration [13]
Patients ≥6 months to

Summary

Introduction

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). Acute gastroenteritis (AGE) complicated by dehydration remains a major cause of childhood morbidity and mortality, requiring significant healthcare expenditure worldwide [1,2,3]. The fluid loss associated with AGE causes dehydration, but can lead to metabolic acidosis and electrolyte disturbances [1, 6, 8, 9]. 0.9 % NaCl, which contains a supraphysiologic chloride concentration, can induce hyperchloremic metabolic acidosis (HCA), which can exacerbate the low serum bicarbonate levels often associated with diarrhea and poor perfusion from dehydration [13]. There is a substantial need to further evaluate alternative isotonic crystalloids as a treatment for AGE [10]

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Conclusion