Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis
Condition: Dehydration; Gastroenteritis
MeSH terms: Gastroenteritis; Dehydration
Intervention: multiple electrolyte solution; saline
Intervention description: IV multiple electrolyte solution dosed as clinically indicated for rehydration; IV solutions dosed as clinically indicated for rehydration
Intervention MeSH terms: Plasma-lyte 148
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 6 Months
Maximum age: 10 Years
Healthy volunteers: No
Keywords: dehydration; gastroenteritis

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. Moderate to severe dehydration (as assessed by Gorelick score13 ≥ 4

          3. ≥ 6 months to < 11 years of age.

          4. Healthy except for the underlying etiology of AGE.

          5. 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:

          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.