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

Dehydration Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477152
• Other study ID #: 1838-003
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2007
• Last updated: November 22, 2011
• Start date: August 2007
• Est. completion date: June 2008

Study information

• Verified date: November 2011
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dehydration

Intervention

Drug:
• hyaluronidase (human recombinant)/rehydration fluid
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Halozyme Therapeutics, PPD

References & Publications (2)

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

Outcome

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