Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

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.

• Dehydration
• Gastroenteritis

• Drug: multiple electrolyte solution
  IV multiple electrolyte solution clinically dosed for rehydration
• Drug: saline
  IV saline solution dosed for clinical rehydration

• Experimental: multiple electrolyte solution
  Intervention: Drug: multiple electrolyte solution
• Active Comparator: saline
  Intervention: Drug: saline

Inclusion Criteria:

1. AGE (etiology: viral or other) resulting in the presentation to the ED deemed in need of IV rehydration. In the 24 hours prior to presentation, the patient must have experienced at least 3 episodes of diarrhea (loose and/or watery stools) and/or nonbilious vomiting.
2. Moderate to severe dehydration (i.e., Gorelick score ≥ 4;)
3. ≥ 6 months to < 11 years of age
4. Healthy except for the underlying etiology of AGE

Exclusion Criteria:

1. AGE that does not require IV rehydration per the ED clinician
2. Gorelick score ≤ 3
3. Bilious vomiting
4. Received > 20 mL/kg IV fluid bolus within 4 hours prior to Study Enrollment
5. Diarrhea lasting > 5 days prior to admission to the ED
6. Chronic vomiting disorder
7. Grossly bloody diarrhea
8. Chronic diarrheal disorder
9. Known hyponatremia within 72 hours prior to enrollment
10. Known hypernatremia within 72 hours prior to enrollment
11. Known hypokalemia within 72 hours of prior to enrollment
12. Known hyperkalemia within 72 hours prior to enrollment

13. The use of any prohibited medications

    • Antacids within 24 hours prior to presentation to the ED and during the study
    • Anti-diarrhea medication within 24 hours prior to presentation to the ED and during the study
    • The systemic use of corticosteroids/corticotropins is prohibited within 72 hours of enrollment
14. Chronic health condition affecting the ability to tolerate fluids or those that result in electrolyte abnormalities or abnormalities of sodium or potassium handling