Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems

Bacteriuria Clinical Trial

Official title:

Retained Urine Volume and Bacteriuria in Traditional Versus Vented Urine Drainage Systems

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02052674
• Other study ID #: 201300634
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 2015
• Est. completion date: April 2015

Study information

• Verified date: July 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacteriuria

Intervention

Device:
• Vented urinary drainage system
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 (?H) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
• Non-vented urinary drainage system
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 (?H) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Secondary	Retained Urine	One potential source for the risk of developing a Urinary Tract Infection (UTI) is related to residual urine volume in the bladder	7 days
Secondary	Presence of biofilms in catheter materials	A key contributor to bacteriuria is formation of biofilms in the catheter and catheter tubing.	7 days