We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01120431
First Posted: May 11, 2010
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Halozyme Therapeutics
Information provided by (Responsible Party):
Baxter Healthcare Corporation
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Rate of successful rehydration in the ED [ Time Frame: 2 to 8 hours ]
    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 ]
  • Amount of rehydration fluid administered [ Time Frame: 2 to 8 hours ]
  • Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver [ Time Frame: 2 to 8 hours ]
  • Occurrence of infusion site pain or other local reactions [ Time Frame: 2 to 8 hours ]
  • Occurrence of other adverse events [ Time Frame: 7 days ]
  • Vital signs [ Time Frame: 2 to 8 hours ]
    Blood pressure, heart rate, respiratory rate, temperature


Enrollment: 0
Anticipated Study Start Date: May 2010
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120431


Sponsors and Collaborators
Baxter Healthcare Corporation
Halozyme Therapeutics
Investigators
Study Director: George Harb, MD, MPH Baxter Healthcare Corporation
  More Information

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT01120431     History of Changes
Other Study ID Numbers: 1838-008
First Submitted: May 7, 2010
First Posted: May 11, 2010
Last Update Posted: May 8, 2017
Last Verified: May 2017

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:
Emergencies
Dehydration
Disease Attributes
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases
Pharmaceutical Solutions