Dehydration Clinical Trial
— INFUSE-PROfficial 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
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.
Status | Completed |
Enrollment | 52 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Months to 10 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Baxter Healthcare Corporation | Halozyme Therapeutics, PPD |
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 subcu — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) | No |
Primary | 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 | At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) | No |
Secondary | Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter | At end of placement of SC catheter | No | |
Secondary | 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. | 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) | No |
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