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
Publication date
August 2016
DOI Publisher
Springer Science and Business Media LLCAbstract
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-seve...
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