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Lack of Patient Enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Povidone-Iodine Irrigation | Experimental | Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal |
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| Standard of Care | No Intervention | Catheter removal with no bladder irrigation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-iodine irrigation | Drug | Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of Urinary Tract Infection (UTI) | Per NHSN defined catheter associated UTI (CAUTI) criteria | 48-72 hours after catheter removal |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of UTI at 7 Days | Per National Healthcare Safety Network (NHSN) defined CAUTI criteria | 7 days after catheter removal |
| Diagnosis of UTI at 28 Days | Per NHSN defined CAUTI criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Hollander, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
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Patients were recruited from the inpatient units of the hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Povidone-Iodine Irrigation | Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal Povidone-iodine irrigation: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique |
| FG001 | Standard of Care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2018 |
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2 arm parallel study with 1 to 1 randomization
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|
| 28 days after catheter removal |
Catheter removal with no bladder irrigation |
| COMPLETED |
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| NOT COMPLETED |
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No patients were randomized to the Povidone-Iodine arm
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| ID | Title | Description |
|---|---|---|
| BG000 | Povidone-Iodine Irrigation | Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal Povidone-iodine irrigation: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique |
| BG001 | Standard of Care | Catheter removal with no bladder irrigation |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Collected from the medical record | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Presence of urinary tract infection | Positive urinary tract infection (UTI) is defined as a positive urinalysis, culture and patient reported UTI symptoms. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diagnosis of Urinary Tract Infection (UTI) | Per NHSN defined catheter associated UTI (CAUTI) criteria | Patients with an indwelling catheter meeting the study eligibility criteria | Posted | 48-72 hours after catheter removal |
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| Secondary | Diagnosis of UTI at 7 Days | Per National Healthcare Safety Network (NHSN) defined CAUTI criteria | Study terminated due to low enrollment | Posted | 7 days after catheter removal |
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| Secondary | Diagnosis of UTI at 28 Days | Per NHSN defined CAUTI criteria | Study terminated due to low enrollment | Posted | 28 days after catheter removal |
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28 days; from study enrollment through the study completion
No patients were enrolled in the povidone-iodine arm of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Povidone-Iodine Irrigation | Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal Povidone-iodine irrigation: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Standard of Care | Catheter removal with no bladder irrigation | 0 | 3 | 0 | 3 | 0 | 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Urology Research | Beaumont Hospital | 248.551.0804 | Deborah.Hasenau@Beaumont.org |
| Apr 4, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 2, 2018 | Apr 4, 2019 | ICF_001.pdf |
| ID | Term |
|---|---|
| D007239 | Infections |
| D055499 | Catheter-Related Infections |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Between 18 and 65 years |
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| >=65 years |
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