Conditions: Dehydration Gastroenteritis
Keywords: dehydration gastroenteritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
The primary objective of this study is to compare the efficacy and safety of the use of a multiple electrolyte solution to the use of saline for the treatment of moderate to severe dehydration due to acute gastroenteritis (AGE) in children.

Detailed description:
The primary objective of this study was to compare the efficacy and safety of the use of Plasma Lyte A to the use of NS for the treatment of moderate to severe dehydration and amelioration of metabolic acidosis due to AGE in children (≥ 6 months to \< 11 years of age) by measuring serum bicarbonate levels.

Arms:
arm 1: Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling. arm 2: Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling.

Interventions: intervention 1: multiple electrolyte solution intervention 2: saline
Intervention descriptions: intervention 1: IV multiple electrolyte solution dosed as clinically indicated for rehydration intervention 2: IV solutions dosed as clinically indicated for rehydration

Protocol document: