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

NCT01275261 | Terminated Phase 2

• 1 other identifier: 10-00820
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Catheter Associated Urinary Tract Infection

Keywords

Stroke; Urinary Tract Infection

Outcome Measures

Primary Outcomes (2)

• Patient comfort.

  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

  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 Outcomes (2)

• Incidence of Urinary Tract infection

  during acute hospitalization, average 4 days after stroke

• Stroke Functional Outcome

  90 days

Study Arms (2)

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.

Behavioral: Nursing protocol to avoid Foley catheter placement

Interventions

Nursing protocol to avoid Foley catheter placement BEHAVIORAL

A specific nursing order protocol will be followed addressing urinary care to try to avoid the use of Foley catheters.

Nursing protocol to avoid Foley Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (5)

• 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.

  PMID: 20156062 BACKGROUND

• 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.

  PMID: 18722511 BACKGROUND

• 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.

  PMID: 14692888 BACKGROUND

• 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.

  PMID: 15175612 BACKGROUND

• 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.

  PMID: 20167905 BACKGROUND

MeSH Terms

Conditions

Stroke; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sharon N Poisson, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 12, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

US (1)