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

Urinary Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03447639
• Other study ID #: 2018-001
• Status: Terminated
• Phase: Phase 4
• Start date: March 29, 2018
• Est. completion date: October 22, 2018

Study information

• Verified date: January 2020
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 22, 2018
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Catheter Bacteraemia
• Catheter Infection
• Catheter-Related Infections
• Catheter; Infection (Indwelling Catheter)
• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

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

Locations

Country	Name	City	State
United States	Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of Urinary Tract Infection (UTI)	Per NHSN defined catheter associated UTI (CAUTI) criteria	48-72 hours after catheter removal
Secondary	Diagnosis of UTI at 7 Days	Per National Healthcare Safety Network (NHSN) defined CAUTI criteria	7 days after catheter removal
Secondary	Diagnosis of UTI at 28 Days	Per NHSN defined CAUTI criteria	28 days after catheter removal