Subcutaneous Rehydration Compared to Intravenous Rehydration

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Halozyme Therapeutics
• Collaborator: Baxter Healthcare Corporation

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.