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
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
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
NCT ID
NCT00477152
First Posted
May 18, 2007
Last Updated
November 22, 2011
Sponsor
Baxter Healthcare Corporation
Collaborators
Halozyme Therapeutics, PPD
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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