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
  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: 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.


Enrollment: 100
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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)
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.
Drug: saline
IV solutions dosed as clinically indicated for rehydration
Other Name: 0.9% Normal Saline

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.

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234883

Locations
United States, Georgia
Emory University/Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Children's Hospital of Atlanta at Scottish Rite
Atlanta, Georgia, United States, 30342
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Texas
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Study Director: Drew Jones, MD Baxter Healthcare
  More Information

No publications provided

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01234883     History of Changes
Other Study ID Numbers: CSPIVTUSA001
Study First Received: November 3, 2010
Results First Received: February 28, 2014
Last Updated: February 28, 2014
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
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014