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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Dehydration
• Intervention / Treatment: Other: Oral rehydration fluid; Drug: Isotonic hydration fluid and recombinant human hyaluronidase

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral rehydration therapy	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; Other Names: oral rehydration salts
Experimental: hylenex-facilitated SC hydration	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; Other Names: Lactated Ringer's solution; 0.9% sodium chloride solution; normal saline solution; rHuPH20; hyelenx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total resource utilization in the ED	2 to 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Time to ED discharge		2 to 8 hours
Amount of rehydration fluid administered		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
Occurrence of other adverse events		7 days
Vital signs	Blood pressure, heart rate, respiratory rate, temperature	2 to 8 hours

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Halozyme Therapeutics

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2010
• Primary Completion (Anticipated): May 1, 2010
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: May 7, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (Estimate): May 11, 2010

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: pediatric; dehydration; hyaluronan; hyaluronidase; fluid therapy; hyaluronoglucosaminidase; hypodermoclysis; clysis; subcutaneous hydration; subcutaneous rehydration; rHuPH20; ORT
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Water-Electrolyte Imbalance; Emergencies; Dehydration; Pharmaceutical Solutions
• Other Study ID Numbers: 1838-008