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Subcutaneous Recombinant Human Hyaluronidase: Workflow Analysis and Emergency Department Design (Hylenex-ED)

This study has been withdrawn prior to enrollment.
(This study was closed before accrual due to FDA recall of Medication)
Baxter Healthcare Corporation
Information provided by (Responsible Party):
John Fontanesi, University of California, San Diego Identifier:
First received: November 24, 2009
Last updated: December 10, 2013
Last verified: December 2013

This is an observational study examining the workflow dynamics and training requirements that support effective use of subcutaneous hydration delivery (a newly FDA approved Baxter product) compared to standard intravenous hydration/medication delivery. Emergency departments already using both Subcutaneous Recombinant Human Hyaluronidase and standard IV hydration will be enrolled. Patients will be receiving the hydration method selected by their emergency department physician and the investigators will then observe:

  1. Patient Throughput

    • Efficiency of patient care and treatment areas
    • Safety of patient care and treatment areas
    • Support Service processes that impact patient flow
  2. Clinical Outcomes

    • Time to conversion from dehydration to hydration'
    • Rate of complications
  3. Satisfaction

    • Staff satisfaction with Subcutaneous hydration vs. Intravenous hydration
    • Patient satisfaction with Subcutaneous hydration vs. Intravenous hydration


Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Subcutaneous Recombinant Human Hyaluronidase: Workflow Analysis and Emergency Department Design

Resource links provided by NLM:

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • elapsed time in Emergency Department [ Time Frame: elapsed time in the Emergency Department is measured from the point a patient enters until they leave ]
    it is hypothesized patients hydrated via Subcutaneous Recombinant Human Hyaluronidase will progress to discharge from the emergency department faster then will patients hydrated via I.V.

Enrollment: 0
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
non-emergent patients in Emergency Departments

Inclusion Criteria:

  • Triaged as stage 3 or more (less acute)

Exclusion Criteria:

  • Triaged as stage 2 or less (more acute), AND arriving for purposes of forensic/criminal evaluations
  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 identifier: NCT01020513

Sponsors and Collaborators
University of California, San Diego
Baxter Healthcare Corporation
Principal Investigator: John M Fontanesi, PhD UCSD School of Medicine, Department of General Internal Medicine
  More Information

Responsible Party: John Fontanesi, Professor, University of California, San Diego Identifier: NCT01020513     History of Changes
Other Study ID Numbers: UCSD-2010-0250
Study First Received: November 24, 2009
Last Updated: December 10, 2013

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Water-Electrolyte Imbalance
Metabolic Diseases processed this record on May 25, 2017