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Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01234883
First received: November 3, 2010
Last updated: February 28, 2014
Last verified: December 2013

November 3, 2010
February 28, 2014
June 2011
February 2013   (final data collection date for primary outcome measure)
Venous Serum Bicarbonate: Modified Intent to Treat Population (mITT); Obtained at Hour 4 [ Time Frame: 4 hour ] [ Designated as safety issue: No ]
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 at Hour 0.
venous serum bicarbonate [ Time Frame: 4 hour ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01234883 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dehydration
  • Gastroenteritis
  • Drug: multiple electrolyte solution
    IV multiple electrolyte solution dosed as clinically indicated for rehydration
    Other Name: Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP)
  • Drug: saline
    IV solutions dosed as clinically indicated for rehydration
    Other Name: 0.9% Normal Saline
  • Experimental: 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: Drug: multiple electrolyte solution
  • Active Comparator: 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: Drug: saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
6 Months to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01234883
CSPIVTUSA001
No
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Not Provided
Study Director: Drew Jones, MD Baxter Healthcare
Baxter Healthcare Corporation
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP