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Long-term Hemodialysis Catheter Removal and Delayed Replacement, Versus Exchange Over a Guidewire to Treat Catheter Related Blood Stream Infection

Primary Purpose

Catheter Related Blood Stream Infection

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
catheter replacement
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Catheter Related Blood Stream Infection

Eligibility Criteria

14 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients end stage renal disease on hemodialysis from tunneled cuffed dialysis catheters with suspected catheter-related bloodstream infection with no identifiable infection source except the catheter were included.

Exclusion Criteria:

  • metastatic infection,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    group A

    group B

    Arm Description

    exchange of the infected catheter with a new one over a guidewire

    removal of the infected catheter followed by delayed placement of a new catheter 3 to 10 days later

    Outcomes

    Primary Outcome Measures

    infection free survival

    Secondary Outcome Measures

    Full Information

    First Posted
    February 10, 2017
    Last Updated
    February 21, 2017
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03054714
    Brief Title
    Long-term Hemodialysis Catheter Removal and Delayed Replacement, Versus Exchange Over a Guidewire to Treat Catheter Related Blood Stream Infection
    Official Title
    Prospective, Randomized Study of Long-term Hemodialysis Catheter Removal, Versus Guidewire Exchange to Treat Catheter Related Blood Stream Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2011 (Actual)
    Primary Completion Date
    November 30, 2016 (Actual)
    Study Completion Date
    November 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Prospective, randomized Study of tunneled cuffed hemodialysis catheter removal and delayed replacement, versus exchange over a guidewire to treat catheter related blood stream infection
    Detailed Description
    The aim of this study was to compare the clinical outcomes of catheter-related (CRBSI) managed with two different strategies: Guidewire exchange of the infected catheter with a new one over a guidewire versus catheter removal with delayed replacement.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Catheter Related Blood Stream Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    798 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Active Comparator
    Arm Description
    exchange of the infected catheter with a new one over a guidewire
    Arm Title
    group B
    Arm Type
    Active Comparator
    Arm Description
    removal of the infected catheter followed by delayed placement of a new catheter 3 to 10 days later
    Intervention Type
    Device
    Intervention Name(s)
    catheter replacement
    Intervention Description
    catheter removal and delayed replacement, versus exchange over a guidewire
    Primary Outcome Measure Information:
    Title
    infection free survival
    Time Frame
    45 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients end stage renal disease on hemodialysis from tunneled cuffed dialysis catheters with suspected catheter-related bloodstream infection with no identifiable infection source except the catheter were included. Exclusion Criteria: metastatic infection,

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35363884
    Citation
    Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.
    Results Reference
    derived

    Learn more about this trial

    Long-term Hemodialysis Catheter Removal and Delayed Replacement, Versus Exchange Over a Guidewire to Treat Catheter Related Blood Stream Infection

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