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Automatic Stop Orders for Urinary Catheters

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00157625
First Posted: September 12, 2005
Last Update Posted: September 12, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
McMaster University
  Purpose
Urinary tract infections are the most common type of hospital-acquired infection. The majority of these infections result from the use of indwelling urinary catheters. Often caregivers leave them in unnecessarily. The purpose of this study is to assess the effectiveness of an automatic stop order (automatic removal or urinary catheters when they no longer needed) in reducing urinary infections.

Condition Intervention
Urinary Tract Infections Behavioral: Automatic stop order

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Automatic Stop Orders for Urinary Catheterization in Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Urinary tract infections

Secondary Outcome Measures:
  • days of indwelling urinary catheterization,
  • symptomatic urinary tract infection,
  • isolation of antimicrobial-resistant bacteria from catheterized urine,
  • antimicrobial use,
  • bacteremia (blood-stream) infection secondary to urinary tract infection,
  • cost

Estimated Enrollment: 630
Study Start Date: April 2003
Estimated Study Completion Date: July 2006
Detailed Description:
We will randomize patients with urinary catheters to either automatic stop orders or to usual care. The primary outcome will be urinary tract infection. Secondary outcomes will include days of indwelling urinary catheterization, symptomatic urinary tract infection, isolation of antimicrobial-resistant bacteria from catheterized urine, antimicrobial use, bacteremia (blood-stream) infection secondary to urinary tract infection, and cost. We hypothesize that use of the automatic stop order will significantly reduce hospital-acquired urinary tract infection.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urinary catheter for less than 48hrs

Exclusion Criteria:

  • Patient with symptomatic urinary tract infection
  • Latex allergy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157625


Locations
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3z5
Henderson Hospital
Hamilton, Ontario, Canada, L8V 1C3
Hamilton General Hospital
Hamilton, Ontario, Canada
Sponsors and Collaborators
Hamilton Health Sciences Corporation
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Mark B Loeb, MD MSc FRCPC McMaster University
  More Information

ClinicalTrials.gov Identifier: NCT00157625     History of Changes
Other Study ID Numbers: 03-24
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: September 12, 2006
Last Verified: September 2006

Keywords provided by McMaster University:
urinary infections, catheters, bacteriuria, trial

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases