search
Back to results

Novel Device for Reducing Catheter-Related Infections

Primary Purpose

Intensive Care

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
silicone catheter boot
Sponsored by
University of Kansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intensive Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admission in the ICU at time of catheter insertion
  • Indication for central venous catheter placement
  • De novo catheter insertion in the subclavian or internal jugular veins

Exclusion Criteria:

  • Anticipated catheter duration < 72 hours
  • Planned guidewire exchange
  • Documented bacteremia within 48 hours prior to catheter placement
  • Extensive skin breakdown near the site of potential catheter placement
  • Emergent line placement
  • Screening labs with ANC < 500 or platelets < 50K
  • Hypersensitivity to cyanoacrylates or formaldehyde
  • Prior enrollment in study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    1

    2

    Arm Description

    Device and standard catheter

    Standard catheter

    Outcomes

    Primary Outcome Measures

    Catheter site inspection

    Secondary Outcome Measures

    Full Information

    First Posted
    April 7, 2009
    Last Updated
    May 1, 2015
    Sponsor
    University of Kansas
    Collaborators
    University of Missouri-Columbia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00878683
    Brief Title
    Novel Device for Reducing Catheter-Related Infections
    Official Title
    Exploring the Use of a Novel Device for Reducing Catheter-Related Bloodstream Infections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Never received IRB approval; Withdrawn before enrollment ever started
    Study Start Date
    July 2009 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Kansas
    Collaborators
    University of Missouri-Columbia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is a pilot study of the safety, tolerability and efficacy of an investigational central venous catheter device used in conjunction with a standard central venous catheter. The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will reduce catheter colonization by bacteria, and may decrease the rate of catheter-related bloodstream infections.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intensive Care

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Device and standard catheter
    Arm Title
    2
    Arm Type
    No Intervention
    Arm Description
    Standard catheter
    Intervention Type
    Device
    Intervention Name(s)
    silicone catheter boot
    Intervention Description
    silicone device using Dermabond
    Primary Outcome Measure Information:
    Title
    Catheter site inspection
    Time Frame
    Baseline, Daily

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Admission in the ICU at time of catheter insertion Indication for central venous catheter placement De novo catheter insertion in the subclavian or internal jugular veins Exclusion Criteria: Anticipated catheter duration < 72 hours Planned guidewire exchange Documented bacteremia within 48 hours prior to catheter placement Extensive skin breakdown near the site of potential catheter placement Emergent line placement Screening labs with ANC < 500 or platelets < 50K Hypersensitivity to cyanoacrylates or formaldehyde Prior enrollment in study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephen Waller, MD
    Organizational Affiliation
    University of Kansas Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Novel Device for Reducing Catheter-Related Infections

    We'll reach out to this number within 24 hrs