Urinary Tract InfectionsPhase 2NCT03101371
Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
A Phase 2 study testing Catheter insertion with Povidone Iodine in people with Urinary Tract Infections and Catheter Infection, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Urinary Tract Infections, Catheter Infection, Catheter-Related Infections
- What is being tested?
- Catheter insertion with Povidone Iodine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2017to 15 Feb 2019
- Phase
- Phase 2
- 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 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women 18-89 years of age
- admitted for surgery lasting >1 hour and requiring urinary catheter,
- have normal urine analysis within 24 hours pre-surgery, and
- able to provide informed consent.
Who cannot join
- currently on dialysis,
- chronic urinary infection,
- hyperthyroidism,
- current infection,
- a history of allergy or sensitivity to iodine.
- women who are pregnant or breast feeding
- men due to their lower incidence of UTIs compared to the female population.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complication and improve cost-effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the environment exposure of the catheter before, during and after insertion.
- Being tested
- Catheter insertion with Povidone Iodine, Standard of care catheter insertion
- Medical subject headings
- Urinary Tract Infections, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter insertion with Povidone IodineDrug
Also called Aseptic protocol for catheter insertion using Povidone Iodine treated catheter
The catheter will be treated with Povidone Iodine prior to insertion.
Standard of care catheter insertionProcedure or surgery
Catheter inserted right out of package.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care catheter insertion | Active comparator | Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. Receives: Procedure: Standard of care catheter insertion |
| Aseptic protocol for catheter insertion | Experimental | Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter Receives: Drug: Catheter insertion with Povidone Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
Participants were monitored for up to 14 days. This was assessed with a rapid urine analysis (UA) test. A urinary tract infection was defined as >10^5 bacterial colony forming units per ML on urine culture regardless of symptoms. This is the number of participants who had at least one CAUTI during the time of observation.
Measured: Within 14 +/- 2 days post-surgery
Secondary outcomes (6)
Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation
Participants were monitored for up to 2 weeks. This is the number of participants who received one method versus the other for catheter discontinuation.
Measured: Day 14 (+/- 2 days)
Average Patient Satisfaction
Participants were monitored at 2 weeks. This was assessed using a Likert scale questionnaire (1 = not at all satisfied, 10 = extremely satisfied). Average patient satisfaction with the catheter was assessed.
Measured: Day14 (+/- 2 days)
Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)
Participants were monitored for up to 14 days. This is the number of participants who had a UTI in the hospital, extending their stay for more than seven days.
Measured: 14 days (+/- 2 days) from surgery
Number of Participants With Closed Drainage System Disrupted During Placement of Catheter
Participants were monitored post surgery until time of discharge. This is the number of participants who had the closed drainage system disrupted during placement of catheter for back fill of the bladder during surgery.
Measured: Day 1 post op
Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason
Participants were monitored up to two weeks. This is the number of participants who had at least one readmission or emergency room visit during the time of observation.
Measured: Day 14 (+/- 2 days)
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
Participants were monitored for up to 2 weeks. This is the number of participants that used any antibiotic during surgery and post-surgery.
Measured: Day 14 (+/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start10 Oct 2017
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
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 Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with normal urinary analysis (UA) pre-surgery will be randomized 1:1 to one of two arms prior to surgery: 1. Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter or 2. Standard of care (SOC) catheter insertion in which catheter is inserted right out of package/non-treated catheter.
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saketh Guntupalli, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101371
- Sponsor's protocol ID
- 16-1096
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2017
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Urinary Tract Infection Rates Using a Controlled Aseptic Protocol for Catheter Insertion
- ClinicalTrials.gov ID
- NCT03101371
- Acronym / sponsor ID
- 16-1096
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Posted 18 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complication and improve cost-effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the environment exposure of the catheter before, during and after insertion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with normal urinary analysis (UA) pre-surgery will be randomized 1:1 to one of two arms prior to surgery: 1. Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter or 2. Standard of care (SOC) catheter insertion in which catheter is inserted right out of package/non-treated catheter.
| Arm | Type | Receives |
|---|---|---|
| Standard of care catheter insertion | Active comparator | Procedure: Standard of care catheter insertionStandard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. |
| Aseptic protocol for catheter insertion | Experimental | Drug: Catheter insertion with Povidone IodineAseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women 18-89 years of age
- admitted for surgery lasting >1 hour and requiring urinary catheter,
- have normal urine analysis within 24 hours pre-surgery, and
- able to provide informed consent.
Key exclusion criteria (7 listed)
- currently on dialysis,
- chronic urinary infection,
- hyperthyroidism,
- current infection,
- a history of allergy or sensitivity to iodine.
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 |
|---|---|---|
| Catheter insertion with Povidone IodineAlso: Aseptic protocol for catheter insertion using Povidone Iodine treated catheterThe catheter will be treated with Povidone Iodine prior to insertion. | Drug | Aseptic protocol for catheter insertion |
| Standard of care catheter insertionCatheter inserted right out of package. | Procedure or surgery | Standard of care catheter insertion |
Primary outcome
Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)
Time frame: Within 14 +/- 2 days post-surgery
Participants were monitored for up to 14 days. This was assessed with a rapid urine analysis (UA) test. A urinary tract infection was defined as >10^5 bacterial colony forming units per ML on urine culture regardless of symptoms. This is the number of participants who had at least one CAUTI during the time of observation.
6 secondary outcomes
Number of Participants Who Received the "Fill and Pull" Versus the "Pull and Void" Method of Catheter Discontinuation
Time frame: Day 14 (+/- 2 days)
Average Patient Satisfaction
Time frame: Day14 (+/- 2 days)
Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)
Time frame: 14 days (+/- 2 days) from surgery
Number of Participants With Closed Drainage System Disrupted During Placement of Catheter
Time frame: Day 1 post op
Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason
Time frame: Day 14 (+/- 2 days)
Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery
Time frame: Day 14 (+/- 2 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 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.
Saketh Guntupalli, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Catheter insertion with Povidone Iodine in people with Urinary Tract Infections and Catheter Infection, run by University of Colorado, Denver 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 10 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 18 Feb 2020). 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?
Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI) (time frame: Within 14 +/- 2 days post-surgery). 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 10 Mar 2020.