Subcutaneous Rehydration Compared to Intravenous Rehydration

Completed · Phase 4

Conditions studied: Dehydration

In brief

Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.

Key facts

Study ID

NCT00773175

Run by

Halozyme Therapeutics

People needed

148

Starts

2008-10-01

Expected to finish

2009-12-01

Last updated by the study team

2018-11-07

Who can join

Age: 0 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children of either gender from one month to ≤10 years of age.
• 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.

You may not qualify if…

• Severe dehydration
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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