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Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria (CAB)

Primary Purpose

Critical Illness, Burns, Surgery

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard of Care
DLC Group
DLCS Group
Sponsored by
Potrero Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Critical Illness focused on measuring urinary catheter

Eligibility Criteria

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

Inclusion Criteria:

  1. Adult (age ≥ 18)
  2. Patient or Legally Authorized Representative (LAR) possess the capacity to provide informed consent
  3. Indication for a urinary bladder catheter (or one currently in place)
  4. Expected urinary catheter requirement ≥ 72 hours
  5. No current urinary tract infection
  6. No current indication for prophylactic antibiotics. If a surgical patient, receive perioperative antibiotics for no greater than 24 hours

Exclusion Criteria:

  1. Inability to receive a urinary bladder catheter
  2. Chronic suprapubic catheter in place
  3. Expected survival < 72 hours
  4. Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery
  5. Surgery of the genitourinary tract in the past 6 months prior to admission
  6. Deemed unfit for the protocol by the investigator for any reason

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Standard of Care

    Drain Line Clearance (DLC) Group

    Drain Line Clearance and Silver (DLCS) Group

    Arm Description

    Patients will receive Standard of Care, commercially available catheter utilized by hospital system.

    Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter.

    Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter.

    Outcomes

    Primary Outcome Measures

    Difference in percentage of catheter-associated bacteriuria
    To study the difference in rate of catheter-associated bacteriuria between SOC catheters and Accuryn silicone or Accuryn silver-doped catheters with active drain line clearance.

    Secondary Outcome Measures

    Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria
    To study the incidence and progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
    Time to Bacteriuria (ASB and CAUTI)
    To study the progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
    Urine Culture Comparisons
    To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag).

    Full Information

    First Posted
    January 22, 2019
    Last Updated
    January 27, 2020
    Sponsor
    Potrero Medical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03816384
    Brief Title
    Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria
    Acronym
    CAB
    Official Title
    Effect of Active Drain Line Clearance With or Without Silver on Catheter-Associated Bacteriuria (The CAB Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Declined to pursue Study due to anticipated low enrollment numbers
    Study Start Date
    January 31, 2020 (Anticipated)
    Primary Completion Date
    January 31, 2020 (Anticipated)
    Study Completion Date
    January 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Potrero Medical

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs. The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of CAUTI in hospitalized patients requiring catheters.
    Detailed Description
    Urinary tract infection (UTI) is the most common healthcare associated infection (HAI) acquired in hospitals and is estimated to account for approximately 13% of hospital infections in the United States, of which 75% are associated with indwelling urinary catheters. It is estimated that between 12-16% adult inpatients will receive an indwelling urinary catheter during their hospital stay. The rate of catheter-associated UTI (CAUTI) are highest in burn ICUs, followed by inpatient medical wards and neurosurgical ICUs. The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of bacteriuria and/or CAUTI in patients requiring catheters for more than 72 hours. This study will also evaluate the efficacy in reducing bacteriuria of the Accuryn silver fabricated silicone catheters.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Illness, Burns, Surgery, Urinary Tract Infections, Bacteriuria
    Keywords
    urinary catheter

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Multi-center, Randomized-Controlled-Trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive Standard of Care, commercially available catheter utilized by hospital system.
    Arm Title
    Drain Line Clearance (DLC) Group
    Arm Type
    Experimental
    Arm Description
    Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter.
    Arm Title
    Drain Line Clearance and Silver (DLCS) Group
    Arm Type
    Experimental
    Arm Description
    Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter.
    Intervention Type
    Device
    Intervention Name(s)
    Standard of Care
    Intervention Description
    Standard of care urinary drainage system.
    Intervention Type
    Device
    Intervention Name(s)
    DLC Group
    Intervention Description
    Urinary drainage system with active drain line clearance and plain silicone catheter.
    Intervention Type
    Device
    Intervention Name(s)
    DLCS Group
    Intervention Description
    Urinary drainage system with active drain line clearance and silver-doped silicone catheter.
    Primary Outcome Measure Information:
    Title
    Difference in percentage of catheter-associated bacteriuria
    Description
    To study the difference in rate of catheter-associated bacteriuria between SOC catheters and Accuryn silicone or Accuryn silver-doped catheters with active drain line clearance.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria
    Description
    To study the incidence and progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
    Time Frame
    30 days
    Title
    Time to Bacteriuria (ASB and CAUTI)
    Description
    To study the progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
    Time Frame
    30 days
    Title
    Urine Culture Comparisons
    Description
    To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag).
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult (age ≥ 18) Patient or Legally Authorized Representative (LAR) possess the capacity to provide informed consent Indication for a urinary bladder catheter (or one currently in place) Expected urinary catheter requirement ≥ 72 hours No current urinary tract infection No current indication for prophylactic antibiotics. If a surgical patient, receive perioperative antibiotics for no greater than 24 hours Exclusion Criteria: Inability to receive a urinary bladder catheter Chronic suprapubic catheter in place Expected survival < 72 hours Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery Surgery of the genitourinary tract in the past 6 months prior to admission Deemed unfit for the protocol by the investigator for any reason
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin Foster, MD
    Organizational Affiliation
    Maricopa Integrated Health System (MIHS)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria

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