Status:
TERMINATED
Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Dehydration
Gastroenteritis
Eligibility:
All Genders
6-10 years
Phase:
PHASE4
Brief 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 ...
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 metaboli...
Eligibility Criteria
Inclusion
- 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
- 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.
- Chronic diarrheal disorder.
- Known hyponatremia (sodium \< 130 mmol/L \[\< 130 mEq/L\]) within 72 hours prior to enrollment.
- Known hypernatremia (sodium \> 155 mmol/L \[\> 155 mEq/L\]) within 72 hours prior to enrollment.
- Known hypokalemia (potassium \< 3.0 mmol/L \[\< 3.0 mEq/L\]) within 72 hours prior to enrollment.
- Known hyperkalemia (potassium \> 5.5 mmol/L \[\> 5.5 mEq/L\]) within 72 hours prior to enrollment.
- 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.
- 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).
- Any reason for urgent or emergency hospital admission or ED stays of \> 12 hours within 14 days preceding presentation to the ED.
- 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.
- 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.
- Subject with a \> 50% expected chance of dying within 6 months, in the Investigator's opinion.
- Known hypersensitivity to either of the investigational products.
- Other serious acute or active conditions that, in the Investigator's opinion, precluded participation in this study.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01234883
Start Date
June 1 2011
End Date
February 1 2013
Last Update
April 26 2018
Active Locations (9)
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1
Emory University/Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
2
Children's Hospital of Atlanta at Scottish Rite
Atlanta, Georgia, United States, 30342
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195