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

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

Research output: Contribution to journalArticle

8 Citations (Scopus)

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).

Original languageEnglish (US)
Article number117
JournalBMC Pediatrics
Volume16
Issue number1
DOIs
StatePublished - Aug 2 2016
Externally publishedYes

Fingerprint

Gastroenteritis
Sodium Chloride
Bicarbonates
Pediatrics
Dehydration
Serum
Safety
Hyperkalemia
Hyponatremia
Fluid Therapy
Plasmalyte A
Double-Blind Method
Abdominal Pain
Physical Examination
Canada
Hospital Emergency Service
Therapeutics
Outcome Assessment (Health Care)

Keywords

  • Balanced fluid therapy
  • Dehydration
  • Gastroenteritis
  • Hyperchloremic metabolic acidosis
  • Plasma-Lyte A
  • Rehydration

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Allen, C. H., Goldman, R. D., Bhatt, S., Simon, H. K., Gorelick, M. H., Spandorfer, P. R., ... Goldstein, S. L. (2016). A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis. BMC Pediatrics, 16(1), [117]. https://doi.org/10.1186/s12887-016-0652-4

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.; Du, Hongyan; Smyth, Brendan J.; Schermer, Carol R.; Goldstein, Stuart L.

In: BMC Pediatrics, Vol. 16, No. 1, 117, 02.08.2016.

Research output: Contribution to journalArticle

Allen, CH, Goldman, RD, Bhatt, S, Simon, HK, Gorelick, MH, Spandorfer, PR, Spiro, DM, Mace, SE, Johnson, DW, Higginbotham, EA, Du, H, Smyth, BJ, Schermer, CR & Goldstein, SL 2016, 'A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis', BMC Pediatrics, vol. 16, no. 1, 117. https://doi.org/10.1186/s12887-016-0652-4
Allen CH, Goldman RD, Bhatt S, Simon HK, Gorelick MH, Spandorfer PR et al. A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis. BMC Pediatrics. 2016 Aug 2;16(1). 117. https://doi.org/10.1186/s12887-016-0652-4
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. / A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis. In: BMC Pediatrics. 2016 ; Vol. 16, No. 1.
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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).",
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AU - Allen, Coburn H.

AU - Goldman, Ran D.

AU - Bhatt, Seema

AU - Simon, Harold K.

AU - Gorelick, Marc H.

AU - Spandorfer, Philip R.

AU - Spiro, David M.

AU - Mace, Sharon E.

AU - Johnson, David W.

AU - Higginbotham, Eric A.

AU - Du, Hongyan

AU - Smyth, Brendan J.

AU - Schermer, Carol R.

AU - Goldstein, Stuart L.

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N2 - 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).

AB - 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).

KW - Balanced fluid therapy

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KW - Hyperchloremic metabolic acidosis

KW - Plasma-Lyte A

KW - Rehydration

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