Trial record 3 of 602 for:
Open Studies | "Gastroenteritis"
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
Recruitment status was Recruiting
Sponsor:
Baxter Healthcare Corporation
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01234883
First received: November 3, 2010
Last updated: April 20, 2011
Last verified: April 2011
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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:
- 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.
- Moderate to severe dehydration (i.e., Gorelick score ≥ 4;)
- ≥ 6 months to < 11 years of age
- Healthy except for the underlying etiology of AGE
Exclusion Criteria:
- AGE that does not require IV rehydration per the ED clinician
- Gorelick score ≤ 3
- Bilious vomiting
- Received > 20 mL/kg IV fluid bolus within 4 hours prior to Study Enrollment
- Diarrhea lasting > 5 days prior to admission to the ED
- Chronic vomiting disorder
- Grossly bloody diarrhea
- Chronic diarrheal disorder
- Known hyponatremia within 72 hours prior to enrollment
- Known hypernatremia within 72 hours prior to enrollment
- Known hypokalemia within 72 hours of prior to enrollment
- Known hyperkalemia within 72 hours prior to enrollment
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
- 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:
|
Gastroenteritis Dehydration 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 22, 2013