Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal
Primary Purpose
Catheter; Infection (Indwelling Catheter), Catheter Infection, Catheter-Related Infections
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Povidone-iodine irrigation
Sponsored by
About this trial
This is an interventional prevention trial for Catheter; Infection (Indwelling Catheter) focused on measuring Catheter associated UTI, Povidine iodine, Bladder Irrigation
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent and the willingness and ability to comply with all aspects of study requirements
- Male
- Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a plan for removal
Exclusion Criteria:
- Patients planned for discharge with an indwelling catheter in place
- Patients unable to report urinary symptoms accurately
- Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other related compounds
- Clinical signs or symptoms of urinary tract infection at the time of consent
- Patients currently being treated for UTI
- Patients currently taking any antibiotic medication, other than vancomycin, linezolid, daptomycin, clindamycin, or metronidazole.
- Patients already taking medications known to potentially irritate the bladder, such as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic agents
- Patients with history of bladder cancer, pelvic radiation or interstitial cystitis
- Patients unable to comply with study requirements
- Any other condition which, per investigators' judgment, may increase patient risk and/or impede the reliability of study data
Sites / Locations
- Beaumont Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Povidone-Iodine Irrigation
Standard of Care
Arm Description
Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal
Catheter removal with no bladder irrigation
Outcomes
Primary Outcome Measures
Diagnosis of Urinary Tract Infection (UTI)
Per NHSN defined catheter associated UTI (CAUTI) criteria
Secondary Outcome Measures
Diagnosis of UTI at 7 Days
Per National Healthcare Safety Network (NHSN) defined CAUTI criteria
Diagnosis of UTI at 28 Days
Per NHSN defined CAUTI criteria
Full Information
NCT ID
NCT03447639
First Posted
February 8, 2018
Last Updated
January 9, 2020
Sponsor
William Beaumont Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT03447639
Brief Title
Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal
Official Title
A Randomized Trial of Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal to Reduce Bacteriuria and Catheter-Associated Urinary Tract Infections
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of Patient Enrollment
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
October 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Over the last decade, there has been great emphasis on reducing the incidence of hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled into the bladder immediately prior to indwelling catheter removal to decrease the risk of subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.
Detailed Description
Indwelling urinary catheters are routinely used in the care of hospitalized patients for a variety of reasons, including monitoring of urine output in critically ill patients, relief of urinary obstruction, and prevention of contamination of decubitus ulcers. Bacteriuria increases by 3-10% each day a catheter is left in place, meaning that by 30 days, generally 100% of patients with indwelling catheters will have bacteria in their urine. The majority of these people do not have urinary tract infections (UTIs), they are merely colonized and do not require treatment.
To define a standard (and ultimately to compare hospitals against each other), a surveillance definition for CAUTI has been developed by the National Healthcare Safety Network (NHSN). While useful for surveillance, the definition does not correlate with clinical UTIs, leading to over diagnosis and over-reporting of UTIs (in other words, those with merely bladder colonization being diagnosed as having a UTI). Despite continuing progress in standard methods of reducing infection rates (including decreasing the number of catheters inserted, ensuring proper catheter maintenance, and removing catheters when no long necessary) there continue to be unacceptably high rates of CAUTIs.
A single dose of povidone-iodine prior to catheter removal seems a novel and promising practice for several reasons. First, we suspect it will be helpful in reducing rates of NHSN defined CAUTI, as these are still diagnosed for 2 days after the catheter is removed. Second, using multiple doses of povidone-iodine would be inadvisable, since we suspect bacteria over time would become resistant even to this antiseptic. Third, we suspect use of an antiseptic is preferable to an antibacterial for preventing further antimicrobial resistance development. Finally, use of this method, as opposed to the suggested use of systemic antibiotics at time of removal, is potentially preferable from the downstream standpoint of less antimicrobial resistance and reduced risk of Clostridium difficile infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter; Infection (Indwelling Catheter), Catheter Infection, Catheter-Related Infections, Catheter Bacteraemia, Urinary Tract Infections
Keywords
Catheter associated UTI, Povidine iodine, Bladder Irrigation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
2 arm parallel study with 1 to 1 randomization
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Povidone-Iodine Irrigation
Arm Type
Experimental
Arm Description
Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Catheter removal with no bladder irrigation
Intervention Type
Drug
Intervention Name(s)
Povidone-iodine irrigation
Other Intervention Name(s)
Betadine
Intervention Description
Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique
Primary Outcome Measure Information:
Title
Diagnosis of Urinary Tract Infection (UTI)
Description
Per NHSN defined catheter associated UTI (CAUTI) criteria
Time Frame
48-72 hours after catheter removal
Secondary Outcome Measure Information:
Title
Diagnosis of UTI at 7 Days
Description
Per National Healthcare Safety Network (NHSN) defined CAUTI criteria
Time Frame
7 days after catheter removal
Title
Diagnosis of UTI at 28 Days
Description
Per NHSN defined CAUTI criteria
Time Frame
28 days after catheter removal
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provide written informed consent and the willingness and ability to comply with all aspects of study requirements
Male
Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a plan for removal
Exclusion Criteria:
Patients planned for discharge with an indwelling catheter in place
Patients unable to report urinary symptoms accurately
Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other related compounds
Clinical signs or symptoms of urinary tract infection at the time of consent
Patients currently being treated for UTI
Patients currently taking any antibiotic medication, other than vancomycin, linezolid, daptomycin, clindamycin, or metronidazole.
Patients already taking medications known to potentially irritate the bladder, such as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic agents
Patients with history of bladder cancer, pelvic radiation or interstitial cystitis
Patients unable to comply with study requirements
Any other condition which, per investigators' judgment, may increase patient risk and/or impede the reliability of study data
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Hollander, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal
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