Gentamicin Bladder Instillation on CAUTI

A Randomized Controlled Trial to Evaluate the Effectiveness of 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.

Study Overview

• Status: Recruiting
• Conditions: Catheter Infection
• Intervention / Treatment: Drug: Gentamicin

Detailed Description

Catheter Associated Urinary Tract Infection (CAUTI) is a hospital acquired infection considered preventable by the Center for Medicare & Medicaid Services (CMS) and originally estimated to cost each individual patient approximately $4700 per infection in 2009 US dollars1. In the inpatient population, more contemporary calculations have associated the per patient cost to have risen to a mean of $13,793 per patient (range $4,694-$29,743)2, with an increased median length of stay of 3.6 days, and a 1.37 increased odds ratio of death3.

CMS understandably has declared CAUTI a "never event", a term coined by the National Quality Forum and used to describe preventable hospital acquired infections4. Since 2008 they have tied this quality metric to severe hospital payment penalties to incentivize prioritization of strategies to decrease CAUTIs.

Despite considerable efforts to remain in compliance with this guidance, and hospitals nationwide implementing safer catheter placement training as well as aggressive early catheter removal protocols, it has become clear that CAUTIs are almost never a never event5. Quantitative analyses of these events have estimated that only 65-70% of CAUTIs are truly preventable with current evidence-based prevention strategies6.

In our intensive care units the pragmatic reasons explaining this phenomenon are abundantly clear. Trauma patients critically injured with multiple spinal, pelvic and long bone fractures, intubated on a ventilator and immobile have substantially higher rates of urine retention when foley catheters are removed aggressively within 72 hours of admission per current infection control protocols. Similarly, neuro critical care patients who incurred a massive stroke or traumatic brain injury who are immobilized from their disabilities do not routinely succeed with early catheter removal protocols. Replacing indwelling foley catheters after multiple failed intermittent urinary catheterizations incurs increased urethral trauma and pain for the patient, increased risk of procedural complications, and increased risk of CAUTI due to repeated urethral instrumentation.

On the basis of and in response to a clear need to develop novel strategies to eliminate CAUTIs in those patients for whom early catheter removal is not deemed clinically appropriate, we collected 8 months of pilot data at our level I trauma center ICU in which we prophylactically instilled an antibiotic containing irrigation solution into the indwelling foley catheters in patients who required catheterization for greater than 3 days. Over the observed pilot period zero CAUTI events were recorded as compared to a comparison control group of trauma patients with identical inclusion criteria for whom 9 "never event" CAUTIs were incurred. These differences were statistically significant.

The current proposal aims to expand this pilot data and conduct a full randomized trial to validate the efficacy of gentamicin antibiotic irrigation in critically ill patients with an indwelling foley catheter of greater than 3 days duration. We plan to expand our patient population to include critically ill patients admitted to the trauma, neuro-critical care and medical ICU units.

The current proposal aims to expand this pilot data and conduct a randomized trial to validate the efficacy of gentamicin antibiotic irrigation in critically ill patients with an indwelling foley catheter of greater than 3 days duration. We plan to expand our patient population to include critically ill patients admitted to the trauma, neuro-critical care and medical ICU units. Our primary research question is: Is prophylactic gentamicin bladder irrigation associated with decreased CAUTI in a cohort of catheterized trauma and neuro critical care patients.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kristina M Kupanoff, PhD; Phone Number: 602-406-5192; Email: Kristina.Kupanoff@commonspirit.org
• Study Contact Backup: Name: Hahn Soe-Lin, MD; Phone Number: 602-406-3874; Email: Hahn.Soe-Lin@commonspirit.org

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Recruiting
      • St. Jpseph's Hospital and Medical Center
      • Contact: Kristina Kupanoff, PhD; Phone Number: 602-406-5192; Email: Kristina.Kupanoff@Commonspirit.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gentamicin; 14.4 mg gentamicin dissolved in 30 mL 0f 0.9% saline administered BID	Drug: Gentamicin; random assignment to gentamicin or placebo bladder instillation to prevent CAUTI (catheterized urinary track infection)
Placebo Comparator: Placebo; 30 mL of 0.9% saline administered BID	Drug: Gentamicin; random assignment to gentamicin or placebo bladder instillation to prevent CAUTI (catheterized urinary track infection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAUTI as primary outcome	positive urine culture	30 days

Collaborators and Investigators

• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Investigators: Principal Investigator: Hahn Soe-Lin, MD, St. Joseph's Hospital and Medical Center, Phoenix

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Estimated): October 8, 2026
• Study Completion (Estimated): October 8, 2026

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: 22-500-243-50-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: No