A Phase 1 interventional study of Vented urinary drainage system and Non-vented urinary drainage system in Bacteriuria, sponsored by University of Florida. Withdrawn. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by University of Florida · Phase 1, Interventional, and Prevention
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.
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.
51 studies on the registry are indexed under Bacteriuria; 3 are open to participants now.
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Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
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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.
Device: 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 (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
Device: Non-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 (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
Also known as: Covidien vented foley catheter, TopVent, Covidien Dover Precision Premium Drainage bag
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.
Also known as: Bard urine drainage system, Conventional catheter, Bard Silver-Coated
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.
Time frame: 7 days
Retained Urine
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
Presence of biofilms in catheter materials
A key contributor to bacteriuria is formation of biofilms in the catheter and catheter tubing.
Time frame: 7 days
No study locations are listed for this record.
The record gives a start of Mar 2015, a primary completion of Apr 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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