StrokePhase 2NCT01275261
Pilot Study of Avoidance of Bladder Catheters in Stroke Patients to Avoid Urinary Tract Infections
A Phase 2 study testing Nursing protocol to avoid Foley catheter placement in people with Stroke and Catheter Associated Urinary Tract Infection, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine whether bladder catheterization can be safely avoided in patients admitted to the hospital with stroke using a nursing protocol, and whether this decreases the incidence of urinary tract infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Catheter Associated Urinary Tract Infection
- What is being tested?
- Nursing protocol to avoid Foley catheter placement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18
- Admission to the neurovascular service at UCSF (from the ED or from an outside hospital)
- Diagnosis of acute stroke or intracerebral hemorrhage
Who cannot join
- Glasgow Coma Scale (GCS) <9
- Need for intubation or sedation
- An active medical problem requiring the use of a bladder catheter (e.g., congestive heart failure exacerbation, acute bladder outlet obstruction)
- Subarachnoid hemorrhage
- Patients who are asymptomatic or have minimal symptoms from stroke
- Bladder catheter already in place for >12 hours
- Contraindication for bladder catheterization
- Evidence of UTI on admission
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Pilot Randomized Trial of a Nursing Protocol to Avoid Bladder Catheterization in Patients With Stroke
The purpose of this study is to determine whether bladder catheterization can be safely avoided in patients admitted to the hospital with stroke using a nursing protocol, and whether this decreases the incidence of urinary tract infections. The investigators hypothesize that the protocol will be tolerated by nurses and patients, and that patients without bladder catheters will have fewer urinary tract infections and better outcomes.
Read the detailed description
Medical complications, both minor and serious, play a large role in post-stroke management and outcome. Infection, especially pneumonia and urinary tract infections (UTI), is one of the most common medical complications of stroke. In addition, immunosuppression secondary to stroke may increase the risk of infection after stroke, and fever secondary to infection may result in poor outcomes. UTIs occur in 3 to 16% of patients within the first week to month after a cerebrovascular event. Compared with patients who do not develop post-stroke UTIs, those who do have a UTI have poorer outcomes; such patients have an approximately 3-fold increased odds of a higher mRS, and a 4.5-fold higher odds for the combined endpoint of death or disability.
Between 15% and 25% of all hospitalized patients receive short-term indwelling urinary catheters, often unnecessarily. In the general medical population, the risk of UTI ranges from 3%-10% per day of catheterization, and approaches 100% after 30 continuous days. Catheter-associated UTI (CAUTI) is the second most commonly reported healthcare-associated infection in acute care hospitals, accounting for approximately one-third of all infections reported to the National Healthcare Safety Network in 2006-2007, and is the leading cause of secondary nosocomial bloodstream infections. CAUTIs have been estimated to cost $589 to $758 per infection, and between 17 and 69% may be preventable.
The recently released draft guidelines from the Centers for Disease Control and Prevention (CDC) for prevention of CAUTI suggest appropriate indications for indwelling urethral catheter use, including acute urinary retention or obstruction, need for accurate measurements of urinary output in critically ill patients, and prolonged immobilization, but an estimated 20 to 50% of hospitalized patients have urinary catheters placed without clear indications.
We will conduct a pilot RCT to determine the tolerability and efficacy of a protocol to avoid catheter placement in patients admitted to the UCSF neurovascular service with ischemic stroke or intracerebral hemorrhage. There are two study arms: a usual care control group will have catheter placement on admission, and the intervention group will not have a catheter placed on admission. The intervention arm will be treated using a protocol, developed with a multidisciplinary team, and instituted by nurses to avoid the need for catheter placement. The sample will be followed during hospital admission, with the main outcome measures being the tolerability of the protocol by the nursing staff, patient comfort and the incidence of UTI during hospitalization. The subjects will be followed during their hospitalization and a follow-up telephone call will be made to them at 90-days post-stroke.
We hypothesize that limiting the use of Foley catheters to the medical indications noted in the CDC guidelines, which is not current standard practice, will decrease the number of catheters placed, and thereby reduce the number of UTIs in stroke patients. The ultimate goal of this study is to improve clinical outcomes, decrease hospital length of stay, cost of care, and time to rehabilitation among patients who suffer a stroke.
- Being tested
- Nursing protocol to avoid Foley catheter placement
- Keywords
- Stroke, Urinary Tract Infection
- Medical subject headings
- Stroke, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing protocol to avoid Foley catheter placementBehavioural
A specific nursing order protocol will be followed addressing urinary care to try to avoid the use of Foley catheters.
| Study group | Role | What they receive |
|---|---|---|
| Foley catheter | No intervention | Usual care - patients will have a Foley catheter placed on admission. |
| Nursing protocol to avoid Foley Catheter | Experimental | No catheter will be placed on admission, and a nursing order protocol will be followed to avoid catheterization and avoid complications. Receives: Behavioral: Nursing protocol to avoid Foley catheter placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient comfort.
This will be assessed using a questionnaire at discharge addressing comfort of urinary care.
Measured: On discharge (average 4 days after stroke)
Amount of time spent by nurses on patient urinary care
This will be assessed using a questionnaire filled out at the end of each nursing shift addressing time management and comfort with the urinary care of the patient.
Measured: Will be measured at the end of each nursing shift during the patients hospitalization.
Secondary outcomes (2)
Incidence of Urinary Tract infection
Determined using UTI symptoms and urinalysis and urine culture findings.
Measured: during acute hospitalization, average 4 days after stroke
Stroke Functional Outcome
Using the modified Rankin Scale by telephone interview.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Investigator no longer at institution-no data analyzed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon N Poisson, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275261
- Sponsor's protocol ID
- 10-00820
- Status last verified
- Nov 2012
- First submitted
- 7 Jan 2011
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available.
PubMed 20156062Klehmet J, Harms H, Richter M, Prass K, Volk HD, Dirnagl U, Meisel A, Meisel C. Stroke-induced immunodepression and post-stroke infections: lessons from the preventive antibacterial therapy in stroke trial. Neuroscience. 2009 Feb 6;158(3):1184-93. doi: 10.1016/j.neuroscience.2008.07.044. Epub 2008 Aug 5.
PubMed 18722511Aslanyan S, Weir CJ, Diener HC, Kaste M, Lees KR; GAIN International Steering Committee and Investigators. Pneumonia and urinary tract infection after acute ischaemic stroke: a tertiary analysis of the GAIN International trial. Eur J Neurol. 2004 Jan;11(1):49-53. doi: 10.1046/j.1468-1331.2003.00749.x.
PubMed 14692888Gokula RR, Hickner JA, Smith MA. Inappropriate use of urinary catheters in elderly patients at a midwestern community teaching hospital. Am J Infect Control. 2004 Jun;32(4):196-9. doi: 10.1016/j.ajic.2003.08.007.
PubMed 15175612Poisson SN, Johnston SC, Josephson SA. Urinary tract infections complicating stroke: mechanisms, consequences, and possible solutions. Stroke. 2010 Apr;41(4):e180-4. doi: 10.1161/STROKEAHA.109.576413. Epub 2010 Feb 18.
PubMed 20167905
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of a Nursing Protocol to Avoid Bladder Catheterization in Patients With Stroke
- ClinicalTrials.gov ID
- NCT01275261
- Acronym / sponsor ID
- 10-00820
- Keywords
- Stroke, Urinary Tract Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator no longer at institution-no data analyzed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether bladder catheterization can be safely avoided in patients admitted to the hospital with stroke using a nursing protocol, and whether this decreases the incidence of urinary tract infections. The investigators hypothesize that the protocol will be tolerated by nurses and patients, and that patients without bladder catheters will have fewer urinary tract infections and better outcomes.
Detailed description
Medical complications, both minor and serious, play a large role in post-stroke management and outcome. Infection, especially pneumonia and urinary tract infections (UTI), is one of the most common medical complications of stroke. In addition, immunosuppression secondary to stroke may increase the risk of infection after stroke, and fever secondary to infection may result in poor outcomes. UTIs occur in 3 to 16% of patients within the first week to month after a cerebrovascular event. Compared with patients who do not develop post-stroke UTIs, those who do have a UTI have poorer outcomes; such patients have an approximately 3-fold increased odds of a higher mRS, and a 4.5-fold higher odds for the combined endpoint of death or disability.
Between 15% and 25% of all hospitalized patients receive short-term indwelling urinary catheters, often unnecessarily. In the general medical population, the risk of UTI ranges from 3%-10% per day of catheterization, and approaches 100% after 30 continuous days. Catheter-associated UTI (CAUTI) is the second most commonly reported healthcare-associated infection in acute care hospitals, accounting for approximately one-third of all infections reported to the National Healthcare Safety Network in 2006-2007, and is the leading cause of secondary nosocomial bloodstream infections. CAUTIs have been estimated to cost $589 to $758 per infection, and between 17 and 69% may be preventable.
The recently released draft guidelines from the Centers for Disease Control and Prevention (CDC) for prevention of CAUTI suggest appropriate indications for indwelling urethral catheter use, including acute urinary retention or obstruction, need for accurate measurements of urinary output in critically ill patients, and prolonged immobilization, but an estimated 20 to 50% of hospitalized patients have urinary catheters placed without clear indications.
We will conduct a pilot RCT to determine the tolerability and efficacy of a protocol to avoid catheter placement in patients admitted to the UCSF neurovascular service with ischemic stroke or intracerebral hemorrhage. There are two study arms: a usual care control group will have catheter placement on admission, and the intervention group will not have a catheter placed on admission. The intervention arm will be treated using a protocol, developed with a multidisciplinary team, and instituted by nurses to avoid the need for catheter placement. The sample will be followed during hospital admission, with the main outcome measures being the tolerability of the protocol by the nursing staff, patient comfort and the incidence of UTI during hospitalization. The subjects will be followed during their hospitalization and a follow-up telephone call will be made to them at 90-days post-stroke.
We hypothesize that limiting the use of Foley catheters to the medical indications noted in the CDC guidelines, which is not current standard practice, will decrease the number of catheters placed, and thereby reduce the number of UTIs in stroke patients. The ultimate goal of this study is to improve clinical outcomes, decrease hospital length of stay, cost of care, and time to rehabilitation among patients who suffer a stroke.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foley catheter | No intervention | –Usual care - patients will have a Foley catheter placed on admission. |
| Nursing protocol to avoid Foley Catheter | Experimental | Behavioral: Nursing protocol to avoid Foley catheter placementNo catheter will be placed on admission, and a nursing order protocol will be followed to avoid catheterization and avoid complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged ≥18
- Admission to the neurovascular service at UCSF (from the ED or from an outside hospital)
- Diagnosis of acute stroke or intracerebral hemorrhage
Key exclusion criteria (8 listed)
- Glasgow Coma Scale (GCS) <9
- Need for intubation or sedation
- An active medical problem requiring the use of a bladder catheter (e.g., congestive heart failure exacerbation, acute bladder outlet obstruction)
- Subarachnoid hemorrhage
- Patients who are asymptomatic or have minimal symptoms from stroke
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 |
|---|---|---|
| Nursing protocol to avoid Foley catheter placementA specific nursing order protocol will be followed addressing urinary care to try to avoid the use of Foley catheters. | Behavioural | Nursing protocol to avoid Foley Catheter |
Primary outcome
Patient comfort.
Time frame: On discharge (average 4 days after stroke)
This will be assessed using a questionnaire at discharge addressing comfort of urinary care.
Amount of time spent by nurses on patient urinary care
Time frame: Will be measured at the end of each nursing shift during the patients hospitalization.
This will be assessed using a questionnaire filled out at the end of each nursing shift addressing time management and comfort with the urinary care of the patient.
2 secondary outcomes
Incidence of Urinary Tract infection
Time frame: during acute hospitalization, average 4 days after stroke
Stroke Functional Outcome
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Investigator no longer at institution-no data analyzed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- Background: PubMed 20156062Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA; Healthcare Infection Control Practices Advisory Committee. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol. 2010 Apr;31(4):319-26. doi: 10.1086/651091. No abstract available.
- Background: PubMed 18722511Klehmet J, Harms H, Richter M, Prass K, Volk HD, Dirnagl U, Meisel A, Meisel C. Stroke-induced immunodepression and post-stroke infections: lessons from the preventive antibacterial therapy in stroke trial. Neuroscience. 2009 Feb 6;158(3):1184-93. doi: 10.1016/j.neuroscience.2008.07.044. Epub 2008 Aug 5.
- Background: PubMed 14692888Aslanyan S, Weir CJ, Diener HC, Kaste M, Lees KR; GAIN International Steering Committee and Investigators. Pneumonia and urinary tract infection after acute ischaemic stroke: a tertiary analysis of the GAIN International trial. Eur J Neurol. 2004 Jan;11(1):49-53. doi: 10.1046/j.1468-1331.2003.00749.x.
- Background: PubMed 15175612Gokula RR, Hickner JA, Smith MA. Inappropriate use of urinary catheters in elderly patients at a midwestern community teaching hospital. Am J Infect Control. 2004 Jun;32(4):196-9. doi: 10.1016/j.ajic.2003.08.007.
- Background: PubMed 20167905Poisson SN, Johnston SC, Josephson SA. Urinary tract infections complicating stroke: mechanisms, consequences, and possible solutions. Stroke. 2010 Apr;41(4):e180-4. doi: 10.1161/STROKEAHA.109.576413. Epub 2010 Feb 18.
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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.
Sharon N Poisson, MD principal investigator
University of California, San Francisco
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 Nursing protocol to avoid Foley catheter placement in people with Stroke and Catheter Associated Urinary Tract Infection, run by University of California, San Francisco 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 8 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 14 Nov 2012. 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?
The study was stopped early (reason given: Investigator no longer at institution-no data analyzed). Results are not available in the source record.
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?
Patient comfort. (time frame: On discharge (average 4 days after stroke)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01275261, which also lists 5 linked publications.
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 14 Nov 2012.