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

NCT ID: NCT03447639

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2018-10-22

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.

Conditions

Catheter; Infection (Indwelling Catheter); Catheter Infection; Catheter-Related Infections; Catheter Bacteraemia; Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Povidone-Iodine Irrigation

Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal

Group Type: EXPERIMENTAL

Povidone-iodine irrigation

Intervention Type: DRUG

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

Standard of Care

Catheter removal with no bladder irrigation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Povidone-iodine irrigation

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

Intervention Type: DRUG

Other Intervention Names

Betadine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Jay Hollander MD

Attending Urologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jay Hollander, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018-001

Identifier Type: -

Identifier Source: org_study_id