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

NCT ID: NCT00477152

Last Updated: 2011-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2008-06-30

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.

Conditions

Dehydration

Keywords

dehydration; fluid therapy; pediatrics; emergency medicine; hyaluronoglucosaminidase; hyaluronidase; hypodermoclysis; clysis; subcutaneous hydration; subcutaneous rehydration; hyaluronan; rHuPH20

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HYLENEX-augmented subcutaneous (SC ) rehydration

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.

Group Type: EXPERIMENTAL

hyaluronidase (human recombinant)/rehydration fluid

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

HYLENEX recombinant

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Halozyme Therapeutics

INDUSTRY

Sponsor Role: collaborator

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George E Harb, MD

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 9113963 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19805455 (View on PubMed)

Other Identifiers

1838-003

Identifier Type: -

Identifier Source: org_study_id