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

Dehydration Clinical Trial

— INFUSE-TM  

Official title:

The INcreased Flow Utilizing Subcutaneously-Enabled Time-Motion (INFUSE-TM) Study: A Randomized, Open-label, Parallel-group, Multicenter Study Evaluating Efficacy and Time and Resources in the Emergency Department for Hylenex-facilitated Subcutaneous Rehydration Versus Oral Rehydration Therapy in Pediatric Patients With Mild to Moderate Dehydration

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01120431
• Other study ID #: 1838-008
• Status: Withdrawn
• Phase: Phase 4
• First received: May 7, 2010
• Last updated: May 5, 2017
• Start date: May 2010
• Est. completion date: May 2010

Study information

• Verified date: May 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Emergencies

Intervention

Other:
• 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

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Halozyme Therapeutics

Outcome

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