Catheter; Infection (Indwelling Catheter)Phase 4NCT03447639
Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal
A Phase 4 study testing Povidone-iodine irrigation in people with Catheter; Infection (Indwelling Catheter) and Catheter Infection, run by Corewell Health East at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Catheter; Infection (Indwelling Catheter), Catheter Infection, Catheter-Related Infections
- What is being tested?
- Povidone-iodine irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2018to 22 Oct 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent and the willingness and ability to comply with all aspects of study requirements
- Male
- Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a plan for removal
Who cannot join
- Patients planned for discharge with an indwelling catheter in place
- Patients unable to report urinary symptoms accurately
- Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other related compounds
- Clinical signs or symptoms of urinary tract infection at the time of consent
- Patients currently being treated for UTI
- Patients currently taking any antibiotic medication, other than vancomycin, linezolid, daptomycin, clindamycin, or metronidazole.
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- Patients already taking medications known to potentially irritate the bladder, such as, but not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic agents
- Patients with history of bladder cancer, pelvic radiation or interstitial cystitis
- Patients unable to comply with study requirements
- Any other condition which, per investigators' judgment, may increase patient risk and/or impede the reliability of study data
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Povidone-iodine irrigation
- Keywords
- Catheter associated UTI, Povidine iodine, Bladder Irrigation
- Medical subject headings
- Infections, Catheter-Related Infections, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-iodine irrigationDrug
Also called Betadine
Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique
| Study group | Role | What they receive |
|---|---|---|
| Povidone-Iodine Irrigation | Experimental | Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal Receives: Drug: Povidone-iodine irrigation |
| Standard of Care | No intervention | Catheter removal with no bladder irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of Urinary Tract Infection (UTI)
Per NHSN defined catheter associated UTI (CAUTI) criteria
Measured: 48-72 hours after catheter removal
Secondary outcomes (2)
Diagnosis of UTI at 7 Days
Per National Healthcare Safety Network (NHSN) defined CAUTI criteria
Measured: 7 days after catheter removal
Diagnosis of UTI at 28 Days
Per NHSN defined CAUTI criteria
Measured: 28 days after catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start29 Mar 2018
- Primary completion18 Oct 2018
- Study completion22 Oct 2018
Why it stopped: Lack of Patient Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Catheter; Infection (Indwelling Catheter)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arm parallel study with 1 to 1 randomization
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Hollander MD, Corewell Health East
- Investigators
- Jay Hollander, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447639
- Sponsor's protocol ID
- 2018-001
- Status last verified
- Jan 2020
- First submitted
- 8 Feb 2018
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03447639
- Acronym / sponsor ID
- 2018-001
- Conditions
- Catheter; Infection (Indwelling Catheter), Catheter Infection, Catheter-Related Infections, Catheter Bacteraemia, Urinary Tract Infections
- Keywords
- Catheter associated UTI, Povidine iodine, Bladder Irrigation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Patient Enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Posted 24 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arm parallel study with 1 to 1 randomization
| Arm | Type | Receives |
|---|---|---|
| Povidone-Iodine Irrigation | Experimental | Drug: Povidone-iodine irrigationBladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal |
| Standard of Care | No intervention | –Catheter removal with no bladder irrigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provide written informed consent and the willingness and ability to comply with all aspects of study requirements
- Male
- Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a plan for removal
Key exclusion criteria (10 listed)
- Patients planned for discharge with an indwelling catheter in place
- Patients unable to report urinary symptoms accurately
- Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other related compounds
- Clinical signs or symptoms of urinary tract infection at the time of consent
- Patients currently being treated for UTI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone-iodine irrigationAlso: BetadineSingle dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique | Drug | Povidone-Iodine Irrigation |
Primary outcome
Diagnosis of Urinary Tract Infection (UTI)
Time frame: 48-72 hours after catheter removal
Per NHSN defined catheter associated UTI (CAUTI) criteria
2 secondary outcomes
Diagnosis of UTI at 7 Days
Time frame: 7 days after catheter removal
Diagnosis of UTI at 28 Days
Time frame: 28 days after catheter removal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Hollander, MD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Povidone-iodine irrigation in people with Catheter; Infection (Indwelling Catheter) and Catheter Infection, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Urinary Tract Infection (UTI) (time frame: 48-72 hours after catheter removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.