Trial record 18 of 43 for:    INFUSE | Industry

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This study has been withdrawn prior to enrollment.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:
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
  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:
  • hyelenx
  • rHuPH20
  • Lactated Ringer's solution
  • normal saline solution
  • 0.9% sodium chloride solution

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120431

Sponsors and Collaborators
Baxter Healthcare Corporation
Halozyme Therapeutics
Investigators
Study Director: George Harb, MD, MPH Baxter Healthcare Corporation
  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
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014