Back to resultsRetained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems
Primary Purpose
Bacteriuria
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Vented urinary drainage system
Non-vented urinary drainage system
Sponsored by
About this trial
This is an interventional prevention trial for Bacteriuria focused on measuring Precursor to CAUTI
Eligibility Criteria
Inclusion Criteria:
- Scheduled for a planned surgery
- Anticipated indwelling bladder catheter placement for greater than 24 hours
- Anticipated post-op admission to a surgical ICU
Exclusion Criteria:
- Unstable renal function as self-reported
- Anticipated bandaged postoperative suprapubic incisions
- Anatomical deformity that precludes appropriate suprapubic access for ultrasound bladder scanning
- Surgical procedure that prevents accurate core body temperature by any means other than by bladder temperature
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vented urinary drainage system
Non-vented urinary drainage system
Arm Description
This group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
This group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
Outcomes
Primary Outcome Measures
Bacteriuria
Evidence of bacteriuria, a potential precursor to Catheter Associated Urinary Tract Infection (CAUTI), will be used to study the potential effect of the vented urinary drainage system intervention on CAUTI.
Secondary Outcome Measures
Retained Urine
One potential source for the risk of developing a Urinary Tract Infection (UTI) is related to residual urine volume in the bladder
Presence of biofilms in catheter materials
A key contributor to bacteriuria is formation of biofilms in the catheter and catheter tubing.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02052674
Brief Title
Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems
Official Title
Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to enroll any patients in the study due to other on-going studies.
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see if there are differences in urine drainage between two types of indwelling bladder catheter systems (Foley catheter) in hospitalized patients. The difference between the two catheters is that one catheter is vented (the study catheter) and the other is a standard non-vented catheter. The vented catheter may drain urine better than a standard non-vented catheter.
If a vented catheter drains the bladder better than a non-vented catheter it may lower the risk of retained urine in the bladder which could help prevent urinary tract infections.
Detailed Description
During hospitalization, while in the surgical intensive care unit beginning the day after surgery, measurements of the subject's urine drainage system will be taken at daily study visits: retained urine volume, dependent loops, incidence of bacteriuria, and thigh diameter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteriuria
Keywords
Precursor to CAUTI
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vented urinary drainage system
Arm Type
Experimental
Arm Description
This group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
Arm Title
Non-vented urinary drainage system
Arm Type
Active Comparator
Arm Description
This group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
Intervention Type
Device
Intervention Name(s)
Vented urinary drainage system
Other Intervention Name(s)
Covidien vented foley catheter, TopVent, Covidien Dover Precision Premium Drainage bag
Intervention Description
This group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
Intervention Type
Device
Intervention Name(s)
Non-vented urinary drainage system
Other Intervention Name(s)
Bard urine drainage system, Conventional catheter, Bard Silver-Coated
Intervention Description
This group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
Primary Outcome Measure Information:
Title
Bacteriuria
Description
Evidence of bacteriuria, a potential precursor to Catheter Associated Urinary Tract Infection (CAUTI), will be used to study the potential effect of the vented urinary drainage system intervention on CAUTI.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Retained Urine
Description
One potential source for the risk of developing a Urinary Tract Infection (UTI) is related to residual urine volume in the bladder
Time Frame
7 days
Title
Presence of biofilms in catheter materials
Description
A key contributor to bacteriuria is formation of biofilms in the catheter and catheter tubing.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled for a planned surgery
Anticipated indwelling bladder catheter placement for greater than 24 hours
Anticipated post-op admission to a surgical ICU
Exclusion Criteria:
Unstable renal function as self-reported
Anticipated bandaged postoperative suprapubic incisions
Anatomical deformity that precludes appropriate suprapubic access for ultrasound bladder scanning
Surgical procedure that prevents accurate core body temperature by any means other than by bladder temperature
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William B. Smith, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems
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