Pilot Study of Avoidance of Bladder Catheters in Stroke Patients to Avoid Urinary Tract Infections
Primary Purpose
Stroke, Catheter Associated Urinary Tract Infection
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nursing protocol to avoid Foley catheter placement
Sponsored by
About this trial
This is an interventional prevention trial for Stroke focused on measuring Stroke, Urinary Tract Infection
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of California San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Foley catheter
Nursing protocol to avoid Foley Catheter
Arm Description
Usual care - patients will have a Foley catheter placed on admission.
No catheter will be placed on admission, and a nursing order protocol will be followed to avoid catheterization and avoid complications.
Outcomes
Primary Outcome Measures
Patient comfort.
This will be assessed using a questionnaire at discharge addressing comfort of urinary care.
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.
Secondary Outcome Measures
Incidence of Urinary Tract infection
Determined using UTI symptoms and urinalysis and urine culture findings.
Stroke Functional Outcome
Using the modified Rankin Scale by telephone interview.
Full Information
NCT ID
NCT01275261
First Posted
January 7, 2011
Last Updated
November 13, 2012
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01275261
Brief Title
Pilot Study of Avoidance of Bladder Catheters in Stroke Patients to Avoid Urinary Tract Infections
Official Title
Pilot Randomized Trial of a Nursing Protocol to Avoid Bladder Catheterization in Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
Investigator no longer at institution-no data analyzed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Catheter Associated Urinary Tract Infection
Keywords
Stroke, Urinary Tract Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Foley catheter
Arm Type
No Intervention
Arm Description
Usual care - patients will have a Foley catheter placed on admission.
Arm Title
Nursing protocol to avoid Foley Catheter
Arm Type
Experimental
Arm Description
No catheter will be placed on admission, and a nursing order protocol will be followed to avoid catheterization and avoid complications.
Intervention Type
Behavioral
Intervention Name(s)
Nursing protocol to avoid Foley catheter placement
Intervention Description
A specific nursing order protocol will be followed addressing urinary care to try to avoid the use of Foley catheters.
Primary Outcome Measure Information:
Title
Patient comfort.
Description
This will be assessed using a questionnaire at discharge addressing comfort of urinary care.
Time Frame
On discharge (average 4 days after stroke)
Title
Amount of time spent by nurses on patient urinary care
Description
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.
Time Frame
Will be measured at the end of each nursing shift during the patients hospitalization.
Secondary Outcome Measure Information:
Title
Incidence of Urinary Tract infection
Description
Determined using UTI symptoms and urinalysis and urine culture findings.
Time Frame
during acute hospitalization, average 4 days after stroke
Title
Stroke Functional Outcome
Description
Using the modified Rankin Scale by telephone interview.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon N Poisson, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20156062
Citation
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.
Results Reference
background
PubMed Identifier
18722511
Citation
Klehmet 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.
Results Reference
background
PubMed Identifier
14692888
Citation
Aslanyan 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.
Results Reference
background
PubMed Identifier
15175612
Citation
Gokula 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.
Results Reference
background
PubMed Identifier
20167905
Citation
Poisson 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.
Results Reference
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Pilot Study of Avoidance of Bladder Catheters in Stroke Patients to Avoid Urinary Tract Infections
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