Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

Exclusion Criteria

• •1. AGE that did not require IV rehydration per the clinician.
• •2. Gorelick score ≤ 3
• •3. Bilious vomiting.
• •4. Received \> 20 mL/kg IV fluid bolus within the 4 hours prior to study enrollment (ie, Hour -4 to Hour 0).
• •5. Diarrhea lasting \> 7 days prior to presentation to the ED.
• •6. Chronic vomiting disorder.
• •7. Grossly bloody diarrhea.
• •8. Chronic diarrheal disorder.
• •9. Known hyponatremia (sodium \< 130 mmol/L \[\< 130 mEq/L\]) within 72 hours prior to enrollment.
• •10. Known hypernatremia (sodium \> 155 mmol/L \[\> 155 mEq/L\]) within 72 hours prior to enrollment.
• •11. Known hypokalemia (potassium \< 3.0 mmol/L \[\< 3.0 mEq/L\]) within 72 hours prior to enrollment.
• •12. Known hyperkalemia (potassium \> 5.5 mmol/L \[\> 5.5 mEq/L\]) within 72 hours prior to enrollment.
• •13. The use of 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 was prohibited within 72 hours of enrollment.
• •14. Chronic health condition affecting the ability to tolerate fluids or those that result in electrolyte abnormalities (eg, chronic renal, cardiac, or pulmonary diagnoses), or abnormalities of sodium or potassium handling (eg, endocrine disorders, medications).
• •15. Any reason for urgent or emergency hospital admission or ED stays of \> 12 hours within 14 days preceding presentation to the ED.
• •16. Any medical condition likely to interfere with the subject's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the subject's need for medical attention beyond that required for treatment of dehydration.
• •17. Participation in a study of any investigational drug or device concomitantly or within 30 days prior to enrollment in this study, including previous enrollment in this study.
• •18. Subject with a \> 50% expected chance of dying within 6 months, in the Investigator's opinion.
• •19. Known hypersensitivity to either of the investigational products.
• •20. Other serious acute or active conditions that, in the Investigator's opinion, precluded participation in this study.