Clinical trial NCT01120431: Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED)
Official title: The INcreased Flow Utilizing Subcutaneously-Enabled Time-Motion (INFUSE-TM) Study: A Randomized, Open-label, Parallel-group, Multicenter Study Evaluating Efficacy and Time and Resources in the Emergency Department for Hylenex-facilitated Subcutaneous Rehydration Versus Oral Rehydration Therapy in Pediatric Patients With Mild to Moderate Dehydration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Dehydration
Keywords: dehydration
fluid therapy
hyaluronoglucosaminidase
hyaluronidase
hypodermoclysis
clysis
subcutaneous hydration
subcutaneous rehydration
hyaluronan
rHuPH20
pediatric
ORT
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Halozyme Therapeutics
First posted: 2010-05-11
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total resource utilization in the ED
timeFrame: 2 to 8 hours
Secondary outcomes:
measure: Rate of successful rehydration in the ED
timeFrame: 2 to 8 hours
measure: Time to ED discharge
timeFrame: 2 to 8 hours
measure: Amount of rehydration fluid administered
timeFrame: 2 to 8 hours
measure: Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver
timeFrame: 2 to 8 hours
measure: Occurrence of infusion site pain or other local reactions
timeFrame: 2 to 8 hours
measure: Occurrence of other adverse events
timeFrame: 7 days
measure: Vital signs
timeFrame: 2 to 8 hours
Other outcomes:
Locations:
Study officials:
affiliation: Baxter Healthcare Corporation
name: George Harb, MD, MPH
role: STUDY_DIRECTOR
References: