Ignite Creation Date:
2024-05-06 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03447639
Status:
TERMINATED
Last Update Posted:
2020-01-18
First Post:
2018-02-08
Brief Title:
Betadine Bladder Irrigations vs Standard of Care Prior to Indwelling Catheter Removal
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Patient Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None