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

Phase 4

Withdrawn

• Conditions: Dehydration
• Interventions: Other: Oral rehydration fluid; Drug: Isotonic hydration fluid and recombinant human hyaluronidase

• Registration Number: NCT01120431
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2010-05-07
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral rehydration therapy	Oral rehydration fluid	-
hylenex-facilitated SC hydration	Isotonic hydration fluid and recombinant human hyaluronidase	-

Primary Outcome Measures

Name	Time	Method
Total resource utilization in the ED	2 to 8 hours

Secondary Outcome Measures

Name	Time	Method
Rate of successful rehydration in the ED	2 to 8 hours	Clinical judgement of adequate hydration, and either: 1) stable or increased body weight or 2) urine production
Occurrence of other adverse events	7 days
Time to ED discharge	2 to 8 hours
Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver	2 to 8 hours
Occurrence of infusion site pain or other local reactions	2 to 8 hours
Amount of rehydration fluid administered	2 to 8 hours
Vital signs	2 to 8 hours	Blood pressure, heart rate, respiratory rate, temperature