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This study has been withdrawn prior to enrollment.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)
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
John Fontanesi, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01020513
First received: November 24, 2009
Last updated: December 10, 2013
Last verified: December 2013
  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:


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 ] [ Designated as safety issue: No ]
    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

  Eligibility

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

non-emergent patients in 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01020513

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, Professor, 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: December 10, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 29, 2014