A Double-Blind, Randomized, Comparative Efficacy and Safety Trial of Intravenous Solutions for the Treatment of Moderate to Severe Dehydration in Children With Acute Gastroenteritis
Overview
- Phase
- Phase 4
- Intervention
- multiple electrolyte solution
- Conditions
- Dehydration
- Sponsor
- Baxter Healthcare Corporation
- Enrollment
- 100
- Locations
- 9
- Primary Endpoint
- Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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 acute gastroenteritis (AGE) in children.
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 metabolic acidosis due to AGE in children (≥ 6 months to \< 11 years of age) by measuring serum bicarbonate levels.
Investigators
Eligibility Criteria
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.
- •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.
Arms & Interventions
multiple electrolyte solution
Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling.
Intervention: multiple electrolyte solution
saline
Subjects were randomized to receive either multiple electrolyte solution or saline. These solutions were administered IV at 10-20 mL/kg until the subject appeared clinically rehydrated as assessed by the clinician. The selected dose for these solutions is considered standard of care when treating clinical dehydration in children and is consistent with product labeling.
Intervention: saline
Outcomes
Primary Outcomes
Change From Baseline of Venous Serum Bicarbonate at 4 Hours From Start of Intravenous (IV)
Time Frame: Day 1 (4 Hours after start of IV)
The primary efficacy variable was venous serum bicarbonate (marker of metabolic acidosis) at Hour 4 (+/- 1 hour) from the start of the First IV Bolus.