Pilot Study of Avoidance of Bladder Catheters in Stroke Patients to Avoid Urinary Tract Infections

November 13, 2012 updated by: University of California, San Francisco

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Foley catheter
Usual care - patients will have a Foley catheter placed on admission.
Experimental: Nursing protocol to avoid Foley Catheter
No catheter will be placed on admission, and a nursing order protocol will be followed to avoid catheterization and avoid complications.
Behavioral: Nursing protocol to avoid Foley catheter placement
A specific nursing order protocol will be followed addressing urinary care to try to avoid the use of Foley catheters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
On discharge (average 4 days after stroke)
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.
Will be measured at the end of each nursing shift during the patients hospitalization.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Urinary Tract infection
Time Frame: during acute hospitalization, average 4 days after stroke
Determined using UTI symptoms and urinalysis and urine culture findings.
during acute hospitalization, average 4 days after stroke
Stroke Functional Outcome
Time Frame: 90 days
Using the modified Rankin Scale by telephone interview.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Sharon N Poisson, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 7, 2011

First Submitted That Met QC Criteria

January 10, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Estimate)

November 14, 2012

Last Update Submitted That Met QC Criteria

November 13, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-00820

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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