Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED) (INFUSE-TM)
This study has been withdrawn prior to enrollment.
(Strategic business decision (not related to safety or efficacy concerns))
Sponsor:
Baxter Healthcare Corporation
Collaborator:
Halozyme Therapeutics
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01120431
First received: May 7, 2010
Last updated: January 28, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dehydration |
Other: Oral rehydration fluid Drug: Isotonic hydration fluid and recombinant human hyaluronidase |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Baxter Healthcare Corporation:
Primary Outcome Measures:
- Total resource utilization in the ED [ Time Frame: 2 to 8 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rate of successful rehydration in the ED [ Time Frame: 2 to 8 hours ] [ Designated as safety issue: No ]Clinical judgement of adequate hydration, and either: 1) stable or increased body weight or 2) urine production
- Time to ED discharge [ Time Frame: 2 to 8 hours ] [ Designated as safety issue: No ]
- Amount of rehydration fluid administered [ Time Frame: 2 to 8 hours ] [ Designated as safety issue: No ]
- Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver [ Time Frame: 2 to 8 hours ] [ Designated as safety issue: No ]
- Occurrence of infusion site pain or other local reactions [ Time Frame: 2 to 8 hours ] [ Designated as safety issue: Yes ]
- Occurrence of other adverse events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- Vital signs [ Time Frame: 2 to 8 hours ] [ Designated as safety issue: Yes ]Blood pressure, heart rate, respiratory rate, temperature
| Estimated Enrollment: | 20 |
| Arms | Assigned Interventions |
|---|---|
| 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 Name: 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:
|
Eligibility| Ages Eligible for Study: | 2 Months to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | George Harb, MD, MPH/Therapeutic Area Leader, Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT01120431 History of Changes |
| Other Study ID Numbers: | 1838-008 |
| Study First Received: | May 7, 2010 |
| Last Updated: | January 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Baxter Healthcare Corporation:
|
dehydration fluid therapy hyaluronoglucosaminidase hyaluronidase hypodermoclysis clysis |
subcutaneous hydration subcutaneous rehydration hyaluronan rHuPH20 pediatric ORT |
Additional relevant MeSH terms:
|
Dehydration Emergencies Water-Electrolyte Imbalance |
Metabolic Diseases Pathologic Processes Disease Attributes |
ClinicalTrials.gov processed this record on May 19, 2013