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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of California, San Diego.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01020513
First received: November 24, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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

Condition
Dehydration

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:

MedlinePlus related topics: Dehydration
U.S. FDA Resources

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

Primary Outcome Measures:
  • time to hydration [ Time Frame: ed visit 3 to 9 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2009
Estimated Study Completion Date: August 2010
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Emergency Departments

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020513

Contacts
Contact: John M Fontanesi, PhD (619) 294-6329 jfontanesi@ucsd.edu

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

No publications provided

Responsible Party: John Fontanesi, PhD , Director, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01020513     History of Changes
Other Study ID Numbers: UCSD-2010-0250
Study First Received: November 24, 2009
Last Updated: November 24, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dehydration
Emergencies
Water-Electrolyte Imbalance
 Metabolic Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on May 19, 2013