Gentamicin Bladder Instillation on CAUTI
Urinary tract infections in catheterized patients is an unacceptable complication and has been termed a 'never event' by the Center for Medicare \& Medicaid Services (CMS); however there is not consensus among clinicians on how to best prevent CAUTIs. We propose a prospective randomized controlled trial to test the efficacy of prophylactic gentamicin bladder irrigation in elimination of CAUTIs.
Conditions:
🦠 Catheter Infection
🗓️ Study Start (Actual) 9 October 2023
🗓️ Primary Completion (Estimated) 8 October 2026
✅ Study Completion (Estimated) 8 October 2026
👥 Enrollment (Estimated) 400
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Phoenix, Arizona, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. age greater than 18
    • 2. admitted with a trauma, surgical, or neuro-critical care diagnosis
    • 3. indwelling foley catheter in place

    Exclusion Criteria:

    • 1. Documented positive UA or Urine Culture within the past 7 days or upon admission
    • 2. Traumatic bladder injury
    • 3. Gross hematuria
    • 4. Chronic indwelling urethral or chronic suprapubic foley catheter
    • 5. allergy to gentamicin or similar aminoglycosides
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 March 2024
  • First Submitted that Met QC Criteria 19 March 2024
  • First Posted 26 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 March 2024
  • Last Update Posted 26 March 2024
  • Last Verified March 2024