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Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children (INFUSE-PR)

Primary Purpose

Dehydration

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
hyaluronidase (human recombinant)/rehydration fluid
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, pediatrics, emergency medicine, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20

Eligibility Criteria

2 Months - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child, 2 months to 10 years of age
  • Body weight less than 42 kg
  • Presenting at emergency department with mild to moderate dehydration (Gorelick dehydration classification: presence of 1 to 6 [of possible 10] moderate or severe signs and symptoms) requiring parenteral rehydration

Exclusion Criteria:

  • In shock or life-threatening situation (other than dehydration)
  • Severe dehydration
  • Requires intravenous (IV) therapy for another indication
  • Indwelling IV catheter (excepting one intended strictly for clinical laboratory sample collection)
  • Already received rehydration therapy IV within prior 48 hours or substantial oral fluid immediately before enrollment
  • Condition precluding subcutaneous injection or infusion site evaluation in anterior thigh or other elected infusion site
  • Reason for hospital admission or extended emergency department stay other than dehydration
  • Known hypersensitivity to hyaluronidase or another ingredient in HYLENEX
  • Hyponatremia or hypernatremia
  • Hypokalemia
  • Medical condition likely to interfere with ability to fully complete study or have protocol-specified assessments
  • Medical history, screening examination finding or historical clinical laboratory result precluding safe participation in study or which might adversely effect interpretation of study results
  • Participated in study of any investigational drug or device within 30 days prior to this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HYLENEX-augmented subcutaneous (SC ) rehydration

    Arm Description

    Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.

    Outcomes

    Primary Outcome Measures

    HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
    Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home
    Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
    Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination

    Secondary Outcome Measures

    Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter
    Post-treatment Gorelick Dehydration Score
    Score indicates the number of moderate-to-severe signs/symptoms of dehydration, based on assessment of each of the following 10 patient parameters: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate and fingertip capillary refill time. Minimum score = 0; maximum score = 10.

    Full Information

    First Posted
    May 18, 2007
    Last Updated
    November 22, 2011
    Sponsor
    Baxter Healthcare Corporation
    Collaborators
    Halozyme Therapeutics, PPD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00477152
    Brief Title
    Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children
    Acronym
    INFUSE-PR
    Official Title
    INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration (INFUSE-Pediatric Rehydration Study): Phase IV Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase (HYLENEX) for Infants and Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.
    Detailed Description
    Pediatric patients (2 months to 10 years of age), presenting to the emergency department (ED) with mild to moderate dehydration and requiring parenteral rehydration, were treated with HYLENEX-augmented subcutaneous (SC) rehydration. An initial volume of 20 mL/kg of isotonic fluid was to be administered by continuous SC infusion over the first hour, and additional SC rehydration could be continued as clinically indicated. The preferred anatomic site for the SC infusion was the anterior thigh, unless there was an overriding preference for an alternate site. The duration of HYLENEX-augmented SC rehydration was to be a minimum of 1 hour and a maximum of 72 hours. The investigator or designee performed a clinical assessment of the subject's hydration status at baseline and at the end of SC infusion or at discharge from the ED. Other assessments of effectiveness and safety were made directly during the rehydration period and ED stay, and by telephone on Days 3 and 7 after discharge from the ED.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HYLENEX-augmented subcutaneous (SC ) rehydration
    Arm Type
    Experimental
    Arm Description
    Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    hyaluronidase (human recombinant)/rehydration fluid
    Other Intervention Name(s)
    HYLENEX recombinant
    Intervention Description
    Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
    Primary Outcome Measure Information:
    Title
    HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
    Description
    Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home
    Time Frame
    At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
    Title
    Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
    Description
    Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination
    Time Frame
    At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
    Secondary Outcome Measure Information:
    Title
    Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter
    Time Frame
    At end of placement of SC catheter
    Title
    Post-treatment Gorelick Dehydration Score
    Description
    Score indicates the number of moderate-to-severe signs/symptoms of dehydration, based on assessment of each of the following 10 patient parameters: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate and fingertip capillary refill time. Minimum score = 0; maximum score = 10.
    Time Frame
    At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Months
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Child, 2 months to 10 years of age Body weight less than 42 kg Presenting at emergency department with mild to moderate dehydration (Gorelick dehydration classification: presence of 1 to 6 [of possible 10] moderate or severe signs and symptoms) requiring parenteral rehydration Exclusion Criteria: In shock or life-threatening situation (other than dehydration) Severe dehydration Requires intravenous (IV) therapy for another indication Indwelling IV catheter (excepting one intended strictly for clinical laboratory sample collection) Already received rehydration therapy IV within prior 48 hours or substantial oral fluid immediately before enrollment Condition precluding subcutaneous injection or infusion site evaluation in anterior thigh or other elected infusion site Reason for hospital admission or extended emergency department stay other than dehydration Known hypersensitivity to hyaluronidase or another ingredient in HYLENEX Hyponatremia or hypernatremia Hypokalemia Medical condition likely to interfere with ability to fully complete study or have protocol-specified assessments Medical history, screening examination finding or historical clinical laboratory result precluding safe participation in study or which might adversely effect interpretation of study results Participated in study of any investigational drug or device within 30 days prior to this study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    George E Harb, MD
    Organizational Affiliation
    Baxter Healthcare Corporation
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9113963
    Citation
    Gorelick MH, Shaw KN, Murphy KO. Validity and reliability of clinical signs in the diagnosis of dehydration in children. Pediatrics. 1997 May;99(5):E6. doi: 10.1542/peds.99.5.e6.
    Results Reference
    background
    PubMed Identifier
    19805455
    Citation
    Allen CH, Etzwiler LS, Miller MK, Maher G, Mace S, Hostetler MA, Smith SR, Reinhardt N, Hahn B, Harb G; INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration Study Collaborative Research Group. Recombinant human hyaluronidase-enabled subcutaneous pediatric rehydration. Pediatrics. 2009 Nov;124(5):e858-67. doi: 10.1542/peds.2008-3588. Epub 2009 Oct 5.
    Results Reference
    result

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    Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children

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