Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED) (INFUSE-TM)
May 5, 2017 updated by: Baxter Healthcare Corporation
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Oral rehydration therapy
|
Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes
Other Names:
|
|
Experimental: hylenex-facilitated SC hydration
|
Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total resource utilization in the ED
Time Frame: 2 to 8 hours
|
2 to 8 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of successful rehydration in the ED
Time Frame: 2 to 8 hours
|
Clinical judgement of adequate hydration, and either: 1) stable or increased body weight or 2) urine production
|
2 to 8 hours
|
|
Time to ED discharge
Time Frame: 2 to 8 hours
|
2 to 8 hours
|
|
|
Amount of rehydration fluid administered
Time Frame: 2 to 8 hours
|
2 to 8 hours
|
|
|
Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver
Time Frame: 2 to 8 hours
|
2 to 8 hours
|
|
|
Occurrence of infusion site pain or other local reactions
Time Frame: 2 to 8 hours
|
2 to 8 hours
|
|
|
Occurrence of other adverse events
Time Frame: 7 days
|
7 days
|
|
|
Vital signs
Time Frame: 2 to 8 hours
|
Blood pressure, heart rate, respiratory rate, temperature
|
2 to 8 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2010
Primary Completion (Anticipated)
May 1, 2010
Study Completion (Anticipated)
May 1, 2010
Study Registration Dates
First Submitted
May 7, 2010
First Submitted That Met QC Criteria
May 10, 2010
First Posted (Estimate)
May 11, 2010
Study Record Updates
Last Update Posted (Actual)
May 8, 2017
Last Update Submitted That Met QC Criteria
May 5, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1838-008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.