Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED)

NCT ID: NCT01120431

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-05-31

Brief Summary

The purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.

Conditions

Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral rehydration therapy

Group Type: ACTIVE_COMPARATOR

Oral rehydration fluid

Intervention Type: OTHER

Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes

hylenex-facilitated SC hydration

Group Type: EXPERIMENTAL

Isotonic hydration fluid and recombinant human hyaluronidase

Intervention Type: DRUG

Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid

Interventions

Oral rehydration fluid

Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes

Intervention Type: OTHER

Isotonic hydration fluid and recombinant human hyaluronidase

Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid

Intervention Type: DRUG

Other Intervention Names

oral rehydration salts; hyelenx; rHuPH20; Lactated Ringer's solution; normal saline solution; 0.9% sodium chloride solution

Eligibility Criteria

Inclusion Criteria

• Male or female and aged 2 months to 2 years
• Presenting to ED with mild or moderate dehydration
• Candidate for both parenteral and oral rehydration therapies
• Healthy, except for underlying etiology for dehydration
• Naive to ORT or having received attempted ORT at home for current occurrence of dehydration.
• Pre-dehydration body weight greater than 5th percentile for age

Exclusion Criteria

• Severe dehydration
• Shock or a life-threatening situation
• Any condition precluding SC infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for SC infusion
• Medical reason or condition precluding administration of ORT
• Indwelling IV catheter (except one intended only for laboratory sample collection) or anticipated need for IV therapy during the study
• Anticipated need for hospitalization(other than for rehydration)
• Known hypersensitivity to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
• Known hyponatremia, hypernatremia or hypokalemia
• Medical condition likely to interfere with ability to fully complete protocol-specified interventions and assessments, or likely to prolong need for medical attention beyond that required for rehydration
• Participation in an investigational drug or device study within 30 days before participation in this study

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

Sponsors

Halozyme Therapeutics

INDUSTRY

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Harb, MD, MPH

Role: STUDY_DIRECTOR

Baxter Healthcare Corporation

Other Identifiers

1838-008

Identifier Type: -

Identifier Source: org_study_id