Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis (NCT01234883) | Clinical Trial Compass
TerminatedPhase 4
Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis
Stopped: Insufficient enrollment
United States100 participantsStarted 2011-06
Plain-language 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.
Who can participate
Age range6 Months – 10 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. AGE (etiology: viral or other) resulting in presentation to the ED deemed in need of IV rehydration. In the 24 hours prior to presentation, the subject experienced at least 3 episodes of diarrhea (loose and/or watery stools) and/or nonbilious vomiting.
✓. Moderate to severe dehydration (as assessed by Gorelick score13 ≥ 4
✓. ≥ 6 months to \< 11 years of age.
✓. Healthy except for the underlying etiology of AGE.
✓. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICFs and privacy language per national regulations (eg, Health Insurance Portability and Accountability Act \[HIPAA\], Personal Information Protection and Electronic Documents Act \[PIPEDA\]) were obtained from the parent/guardian prior to any study-related procedures.
Exclusion criteria
✕. AGE that did not require IV rehydration per the clinician.
✕. Gorelick score ≤ 3
✕. Bilious vomiting.
✕. Received \> 20 mL/kg IV fluid bolus within the 4 hours prior to study enrollment (ie, Hour -4 to Hour 0).
✕. Diarrhea lasting \> 7 days prior to presentation to the ED.
✕. Chronic vomiting disorder.
✕. Grossly bloody diarrhea.
What they're measuring
1
Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)