Subcutaneous Rehydration Compared to Intravenous Rehydration
NCT ID: NCT00773175
Last Updated: 2018-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
148 participants
INTERVENTIONAL
2008-10-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subcutaneous
Isotonic fluid rehydration by SC administration with hylenex (150 Units in 1 mL)
recombinant human hyaluronidase
150 Units in 1 mL
Intravenous
Isotonic fluid rehydration by IV
recombinant human hyaluronidase
150 Units in 1 mL
Interventions
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recombinant human hyaluronidase
150 Units in 1 mL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with mild or moderate dehydration
* Healthy child except for the underlying etiology for dehydration
* Pre-dehydration body weight ≥ 5th percentile for age
* Parents or legal guardian(s) available to provide informed consent.
Exclusion Criteria
* Shock or life-threatening situation (life expectancy \< 10 days).
* Requirement for IV access for any indication other than for treatment of dehydration.
* Indwelling IV catheter, except for one intended only for collection of clinical laboratory specimens.
* Any condition precluding SC infusion or infusion site evaluation
* Any reason (prior to study enrollment) for a hospital admission or an extended stay in the ED for other than dehydration.
* Known hypersensitivity to hyaluronidase or hylenex.
* Known hyponatremia (\< 130 milliequivalents per liter \[mEq/L\]) or hypernatremia (\> 155 mEq/L).
* Known hypokalemia (\< 3.0 mEq/L).
* Any medical condition likely to interfere with the patient's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the patient's need for medical attention beyond that required for treatment of dehydration.
* Participation in an investigational drug or device study within 30 days prior to enrollment in this study.
30 Days
10 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Halozyme Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Coburn H Allen, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Connecticut Children's Medical Center
Hartford, Connecticut, United States
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Tampa General Hospital Children's Medical Center
Tampa, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, United States
North Georgia Clinical Research
Dalton, Georgia, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Memorial Hospital
South Bend, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
William Beaumont Hospital
Troy, Michigan, United States
The Children's Mercy Hospital & Clinics
Kansas City, Missouri, United States
UMDNJ/Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
St. Joseph's Children's Hospital
Paterson, New Jersey, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
New York Methodist Hospital
Brooklyn, New York, United States
Staten Island University Hospital Emergency Department
Staten Island, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
Rainbow Children's and Babies Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Dell Children's Medical Center
Austin, Texas, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Countries
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References
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Spandorfer PR, Mace SE, Okada PJ, Simon HK, Allen CH, Spiro DM, Friend K, Harb G, Lebel F; Increased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration II (INFUSE-Peds II) Study Group. A randomized clinical trial of recombinant human hyaluronidase-facilitated subcutaneous versus intravenous rehydration in mild to moderately dehydrated children in the emergency department. Clin Ther. 2012 Nov;34(11):2232-45. doi: 10.1016/j.clinthera.2012.09.011. Epub 2012 Oct 11.
Other Identifiers
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HZ2-08-03
Identifier Type: -
Identifier Source: org_study_id
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