Clinical trial NCT03447639: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Catheter; Infection (Indwelling Catheter)
Catheter Infection
Catheter-Related Infections
Catheter Bacteraemia
Urinary Tract Infections
Keywords: Catheter associated UTI
Povidine iodine
Bladder Irrigation
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm parallel study with 1 to 1 randomization
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent and the willingness and ability to comply with all aspects of study requirements
2. Male
3. Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a plan for removal

Exclusion Criteria:

1. Patients planned for discharge with an indwelling catheter in place
2. Patients unable to report urinary symptoms accurately
3. Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other related compounds
4. Clinical signs or symptoms of urinary tract infection at the time of consent
5. Patients currently being treated for UTI
6. Patients currently taking any antibiotic medication, other than vancomycin, linezolid, daptomycin, clindamycin, or metronidazole.
7. Patients already taking medications known to potentially irritate the bladder, such as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic agents
8. Patients with history of bladder cancer, pelvic radiation or interstitial cystitis
9. Patients unable to comply with study requirements
10. Any other condition which, per investigators' judgment, may increase patient risk and/or impede the reliability of study data

Primary outcomes:
measure: Diagnosis of Urinary Tract Infection (UTI)
timeFrame: 48-72 hours after catheter removal
Secondary outcomes:
measure: Diagnosis of UTI at 7 Days
timeFrame: 7 days after catheter removal
measure: Diagnosis of UTI at 28 Days
timeFrame: 28 days after catheter removal
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Jay Hollander, MD
role: PRINCIPAL_INVESTIGATOR
References: