Bladder Lavage as Decontamination Method for Asymptomatic Bacteriuria With Uropathogens in Catheterized Patients
Primary Purpose
Catheter Related Infections
Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
bladder lavage
Sponsored by
About this trial
This is an interventional prevention trial for Catheter Related Infections focused on measuring urinary catheter, UTI, bladder lavage
Eligibility Criteria
Inclusion Criteria:
- patients with an indwelling catheter
- catheter associated bacteriuria with proteus, enterobacteriaceae or pseudomonas
- willing and able to give informed consent to the study
Exclusion Criteria:
- patients with a clinically relevant UTI ( fever, pain or cloudy urine)
- cognitively impaired patients
- patients not able or willing to give informed consent
- patients with allergies for ISobetadine dermicum or other substances used in the protocol
- patients who only have a catheter for less than 1 month
- patients taking systemic antibiotics during the last 48h
Sites / Locations
- National MS Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Active Comparator
Arm Label
lavage Isobetadine Dermicum solution
lavage Acetic Acid solution
lavage with saline
lavage Urotainer Suby G
Arm Description
Patient will receive 1 bladder lavage daily with a solution of 5ml Isobetadine Dermicum in 100cc saline
Patients will receive a daily bladder lavage during 5 consecutive days with a solution of 0.5% acetic acid in 100cc of saline
patients will receive during 5 consecutive days a bladder lavage with 100cc saline
patients will receive during 5 consecutive days a bladder lavage with 100cc of Urotainer Suby G
Outcomes
Primary Outcome Measures
urinary culture
After 5 consecutive days of bladder lavage, a urine culture will be taken at day 2 and 5. A count of <100.000 CFU/ml and is considered a positive result.
The outcome will be considered positive if this positive result is found in more than 30% of subjects.
Secondary Outcome Measures
pyuria
changes in white blood cell count are monitored at day 2 and 5 afte 5 consecutive days of bladder lavage. This is an assessment of bladder irritation.
Full Information
NCT ID
NCT01772875
First Posted
January 17, 2013
Last Updated
August 3, 2020
Sponsor
National Multiple Sclerosis Center
Collaborators
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01772875
Brief Title
Bladder Lavage as Decontamination Method for Asymptomatic Bacteriuria With Uropathogens in Catheterized Patients
Official Title
Pilot Study to Evaluate the Efficacy of Antiseptic Bladder Lavage Versus Pulsatile Lavage With Physiologic Serum in Catheterized Patients With Asymptomatic Bacteriuria With Uropathogens.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
no clinical investigator present
Study Start Date
January 2013 (Anticipated)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
January 20, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Multiple Sclerosis Center
Collaborators
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In patients with advanced multiple sclerosis, permanent urinary catheters are often used to manage the urinary incontinence and bladder emptying problems. These catheters will lead to urinary tract infection, blocking of the catheter etc.. Especially infections with certain bacteria such as proteus, enterobacteriaceae and ESBL producing enterobacteriaceae and pseudomonas can pose a problem for the hospital infection control and for the patient.
This study wants to evaluate the potential role of regular bladder lavage with saline, a solution of betadine, an acid solution of acetic acid and of URotainer Twin Suby G ( Braun)in the decontamination of these bladders and the prevention of clinically relevant urinary tract infections.
Detailed Description
PAtients will be selected from the catheterised patient population of the National MS Center in Belgium for this prospective randomised comparative pilot studyon bladder lavage.
The potential benefit for the patient is a reduction in number of clinical urinary tract infections and a reduction of antibiotic use.
According to the type of bacteria that is cultured from the urine, patients will be allocated to one of 4 subgroups:
30 patients will recieve bladder lavage with a Isobetadine Dermicum Solution
20 patients will revieve bladder lavage with acetic acid solutions
10 patients will recieve bladder lavage with saline
10 patients will receive bladder lavage with Urotainer Suby G
The effect will be measured by two repeat urine cultures after the bladder lavage( 2days and 5 days).
From a safety perspective and to assess the irritation caused by the lavage, white blood cell counts in the urine will be done.
Adverse events will be monitored according to GCP regulations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Related Infections
Keywords
urinary catheter, UTI, bladder lavage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lavage Isobetadine Dermicum solution
Arm Type
Active Comparator
Arm Description
Patient will receive 1 bladder lavage daily with a solution of 5ml Isobetadine Dermicum in 100cc saline
Arm Title
lavage Acetic Acid solution
Arm Type
Active Comparator
Arm Description
Patients will receive a daily bladder lavage during 5 consecutive days with a solution of 0.5% acetic acid in 100cc of saline
Arm Title
lavage with saline
Arm Type
Sham Comparator
Arm Description
patients will receive during 5 consecutive days a bladder lavage with 100cc saline
Arm Title
lavage Urotainer Suby G
Arm Type
Active Comparator
Arm Description
patients will receive during 5 consecutive days a bladder lavage with 100cc of Urotainer Suby G
Intervention Type
Procedure
Intervention Name(s)
bladder lavage
Other Intervention Name(s)
bladder rincing
Intervention Description
the bladder is rinced through the urinary catheter with the lavage solution
Primary Outcome Measure Information:
Title
urinary culture
Description
After 5 consecutive days of bladder lavage, a urine culture will be taken at day 2 and 5. A count of <100.000 CFU/ml and is considered a positive result.
The outcome will be considered positive if this positive result is found in more than 30% of subjects.
Time Frame
day 2 and day 5 after last bladder lavage
Secondary Outcome Measure Information:
Title
pyuria
Description
changes in white blood cell count are monitored at day 2 and 5 afte 5 consecutive days of bladder lavage. This is an assessment of bladder irritation.
Time Frame
day 2 and day 5 after the last bladder lavage
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with an indwelling catheter
catheter associated bacteriuria with proteus, enterobacteriaceae or pseudomonas
willing and able to give informed consent to the study
Exclusion Criteria:
patients with a clinically relevant UTI ( fever, pain or cloudy urine)
cognitively impaired patients
patients not able or willing to give informed consent
patients with allergies for ISobetadine dermicum or other substances used in the protocol
patients who only have a catheter for less than 1 month
patients taking systemic antibiotics during the last 48h
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk De Ridder, Prof.
Organizational Affiliation
National MS Center Belgium & University Hospitals KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
National MS Center
City
Steenokkerzeel
State/Province
Vlaams-Brabant
ZIP/Postal Code
1820
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
23205350
Citation
Jaggi N, Sissodia P. Multimodal supervision programme to reduce catheter associated urinary tract infections and its analysis to enable focus on labour and cost effective infection control measures in a tertiary care hospital in India. J Clin Diagn Res. 2012 Oct;6(8):1372-6. doi: 10.7860/JCDR/2012/4229.2362.
Results Reference
background
Links:
URL
http://www.mscenter.be
Description
website of the National MS Center, Belgium
Learn more about this trial
Bladder Lavage as Decontamination Method for Asymptomatic Bacteriuria With Uropathogens in Catheterized Patients
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