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Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED) (INFUSE-TM)

Primary Purpose

Dehydration

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oral rehydration fluid
Isotonic hydration fluid and recombinant human hyaluronidase
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dehydration focused on measuring dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20, pediatric, ORT

Eligibility Criteria

2 Months - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Oral rehydration therapy

    hylenex-facilitated SC hydration

    Arm Description

    Outcomes

    Primary Outcome Measures

    Total resource utilization in the ED

    Secondary Outcome Measures

    Rate of successful rehydration in the ED
    Clinical judgement of adequate hydration, and either: 1) stable or increased body weight or 2) urine production
    Time to ED discharge
    Amount of rehydration fluid administered
    Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver
    Occurrence of infusion site pain or other local reactions
    Occurrence of other adverse events
    Vital signs
    Blood pressure, heart rate, respiratory rate, temperature

    Full Information

    First Posted
    May 7, 2010
    Last Updated
    May 5, 2017
    Sponsor
    Baxter Healthcare Corporation
    Collaborators
    Halozyme Therapeutics
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01120431
    Brief Title
    Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED)
    Acronym
    INFUSE-TM
    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

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Strategic business decision (not related to safety or efficacy concerns)
    Study Start Date
    May 2010 (Anticipated)
    Primary Completion Date
    May 2010 (Anticipated)
    Study Completion Date
    May 2010 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Baxter Healthcare Corporation
    Collaborators
    Halozyme Therapeutics

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dehydration
    Keywords
    dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20, pediatric, ORT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral rehydration therapy
    Arm Type
    Active Comparator
    Arm Title
    hylenex-facilitated SC hydration
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Oral rehydration fluid
    Other Intervention Name(s)
    oral rehydration salts
    Intervention Description
    Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    Isotonic hydration fluid and recombinant human hyaluronidase
    Other Intervention Name(s)
    hyelenx, rHuPH20, Lactated Ringer's solution, normal saline solution, 0.9% sodium chloride solution
    Intervention Description
    Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid
    Primary Outcome Measure Information:
    Title
    Total resource utilization in the ED
    Time Frame
    2 to 8 hours
    Secondary Outcome Measure Information:
    Title
    Rate of successful rehydration in the ED
    Description
    Clinical judgement of adequate hydration, and either: 1) stable or increased body weight or 2) urine production
    Time Frame
    2 to 8 hours
    Title
    Time to ED discharge
    Time Frame
    2 to 8 hours
    Title
    Amount of rehydration fluid administered
    Time Frame
    2 to 8 hours
    Title
    Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver
    Time Frame
    2 to 8 hours
    Title
    Occurrence of infusion site pain or other local reactions
    Time Frame
    2 to 8 hours
    Title
    Occurrence of other adverse events
    Time Frame
    7 days
    Title
    Vital signs
    Description
    Blood pressure, heart rate, respiratory rate, temperature
    Time Frame
    2 to 8 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    George Harb, MD, MPH
    Organizational Affiliation
    Baxter Healthcare Corporation
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED)

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