Dehydration
Conditions
Keywords
dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20, pediatric, ORT
Brief summary
The purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.
Interventions
OTHEROral rehydration fluid
Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes
DRUGIsotonic hydration fluid and recombinant human hyaluronidase
Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid
Sponsors
Halozyme Therapeutics
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
* Male or female and aged 2 months to 2 years * Presenting to ED with mild or moderate dehydration * Candidate for both parenteral and oral rehydration therapies * Healthy, except for underlying etiology for dehydration * Naive to ORT or having received attempted ORT at home for current occurrence of dehydration. * Pre-dehydration body weight greater than 5th percentile for age
Exclusion criteria
* Severe dehydration * Shock or a life-threatening situation * Any condition precluding SC infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for SC infusion * Medical reason or condition precluding administration of ORT * Indwelling IV catheter (except one intended only for laboratory sample collection) or anticipated need for IV therapy during the study * Anticipated need for hospitalization(other than for rehydration) * Known hypersensitivity to hyaluronidase or any other ingredient in the formulation of hylenex recombinant * Known hyponatremia, hypernatremia or hypokalemia * Medical condition likely to interfere with ability to fully complete protocol-specified interventions and assessments, or likely to prolong need for medical attention beyond that required for rehydration * Participation in an investigational drug or device study within 30 days before participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total resource utilization in the ED | 2 to 8 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to ED discharge | 2 to 8 hours | — |
| Amount of rehydration fluid administered | 2 to 8 hours | — |
| Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver | 2 to 8 hours | — |
| Rate of successful rehydration in the ED | 2 to 8 hours | Clinical judgement of adequate hydration, and either: 1) stable or increased body weight or 2) urine production |
| Occurrence of other adverse events | 7 days | — |
| Vital signs | 2 to 8 hours | Blood pressure, heart rate, respiratory rate, temperature |
| Occurrence of infusion site pain or other local reactions | 2 to 8 hours | — |
Outcome results
None listed