NCT01234883

Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

A Double-Blind, Randomized, Comparative Efficacy and Safety Trial of Intravenous Solutions for the Treatment of Moderate to Severe Dehydration in Children With Acute Gastroenteritis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 6 Months – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dehydration
• Gastroenteritis

Interventions

Type	Name	Description
DRUG	multiple electrolyte solution	IV multiple electrolyte solution dosed as clinically indicated for rehydration
DRUG	saline	IV solutions dosed as clinically indicated for rehydration

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-11-04
• Last updated: 2018-04-26
• Results posted: 2014-04-07

Locations

9 sites across 2 countries: United States, Canada