Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal
| Status: | Terminated |
|---|---|
| Conditions: | Other Indications, Infectious Disease, Infectious Disease, Urology, Urinary Tract Infections |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/9/2018 |
| Start Date: | March 29, 2018 |
| End Date: | October 22, 2018 |
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
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.
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.
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.
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.
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
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