Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Baxter Healthcare Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01234883
First received: November 3, 2010
Last updated: April 20, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Dehydration
Gastroenteritis
Drug: multiple electrolyte solution
Drug: saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • venous serum bicarbonate [ Time Frame: 4 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 112
Study Start Date: December 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: multiple electrolyte solution Drug: multiple electrolyte solution
IV multiple electrolyte solution clinically dosed for rehydration
Active Comparator: saline Drug: saline
IV saline solution dosed for clinical rehydration

  Eligibility

Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. AGE (etiology: viral or other) resulting in the presentation to the ED deemed in need of IV rehydration. In the 24 hours prior to presentation, the patient must have experienced at least 3 episodes of diarrhea (loose and/or watery stools) and/or nonbilious vomiting.
  2. Moderate to severe dehydration (i.e., Gorelick score ≥ 4;)
  3. ≥ 6 months to < 11 years of age
  4. Healthy except for the underlying etiology of AGE

Exclusion Criteria:

  1. AGE that does not require IV rehydration per the ED clinician
  2. Gorelick score ≤ 3
  3. Bilious vomiting
  4. Received > 20 mL/kg IV fluid bolus within 4 hours prior to Study Enrollment
  5. Diarrhea lasting > 5 days prior to admission to the ED
  6. Chronic vomiting disorder
  7. Grossly bloody diarrhea
  8. Chronic diarrheal disorder
  9. Known hyponatremia within 72 hours prior to enrollment
  10. Known hypernatremia within 72 hours prior to enrollment
  11. Known hypokalemia within 72 hours of prior to enrollment
  12. Known hyperkalemia within 72 hours prior to enrollment
  13. The use of any 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 is prohibited within 72 hours of enrollment
  14. Chronic health condition affecting the ability to tolerate fluids or those that result in electrolyte abnormalities or abnormalities of sodium or potassium handling
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234883

Contacts
Contact: Katherine Weber, BS 847-948-3037 katherine_weber@baxter.com
Contact: Carol Schermer, MD 847-948-4124 carol_schermer@baxter.com

Locations
United States, Georgia
Recruiting
Atlanta, Georgia, United States
Principal Investigator: Phillip Spandorfer, MD            
Recruiting
Atlanta, Georgia, United States
Principal Investigator: Harold Simon, MD            
United States, Ohio
Recruiting
Cincinnati, Ohio, United States
Principal Investigator: Seema Bhatt, MD            
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States
Contact: Elizabeth Gaul            
Principal Investigator: Sharon Mace, MD            
United States, Oregon
Recruiting
Portland, Oregon, United States
Principal Investigator: David Spiro, MD            
United States, Texas
Recruiting
Austin, Texas, United States
Principal Investigator: Coburn Allen, MD            
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States
Principal Investigator: Marc Gorelick, MD            
Canada, Alberta
Recruiting
Edmonton, Alberta, Canada
Principal Investigator: David Johnson, MD            
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada
Principal Investigator: Ran Goldman, MD            
Sponsors and Collaborators
Baxter Healthcare Corporation
  More Information

No publications provided

Responsible Party: Katherine Weber, Baxter Healthcare
ClinicalTrials.gov Identifier: NCT01234883     History of Changes
Other Study ID Numbers: CSPIVTUSA001
Study First Received: November 3, 2010
Last Updated: April 20, 2011
Health Authority: United States: Institutional Review Board
Canada: Health Canada

Keywords provided by Baxter Healthcare Corporation:
dehydration
gastroenteritis

Additional relevant MeSH terms:
Dehydration
Gastroenteritis
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Citric Acid
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013