Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 18, 2018

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.

Interventions

  • Drug: Povidone-iodine irrigation
    • Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique

Arms, Groups and Cohorts

  • Experimental: Povidone-Iodine Irrigation
    • Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal
  • No Intervention: Standard of Care
    • Catheter removal with no bladder irrigation

Clinical Trial Outcome Measures

Primary Measures

  • Diagnosis of Urinary Tract Infection (UTI)
    • Time Frame: 48-72 hours after catheter removal
    • Per NHSN defined catheter associated UTI (CAUTI) criteria

Secondary Measures

  • Diagnosis of UTI at 7 Days
    • Time Frame: 7 days after catheter removal
    • Per National Healthcare Safety Network (NHSN) defined CAUTI criteria
  • Diagnosis of UTI at 28 Days
    • Time Frame: 28 days after catheter removal
    • Per NHSN defined CAUTI criteria

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • William Beaumont Hospitals
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jay Hollander MD, Attending Urologist – William Beaumont Hospitals
  • Overall Official(s)
    • Jay Hollander, MD, Principal Investigator, William Beaumont Hospitals

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