- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00157625
Automatic Stop Orders for Urinary Catheters
October 25, 2018 updated by: McMaster University
A Randomized Controlled Trial of Automatic Stop Orders for Urinary Catheterization in Hospitalized Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
630
Phase
- Not Applicable
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
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster University Medical Centre
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Hamilton, Ontario, Canada
- Hamilton General Hospital
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Hamilton, Ontario, Canada, L8V 1C3
- Henderson Hospital
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-
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:
- Urinary catheter for less than 48hrs
Exclusion Criteria:
- Patient with symptomatic urinary tract infection
- Latex allergy
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
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Urinary tract infections
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Secondary Outcome Measures
Outcome Measure |
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cost
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days of indwelling urinary catheterization,
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symptomatic urinary tract infection,
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isolation of antimicrobial-resistant bacteria from catheterized urine,
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antimicrobial use,
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bacteremia (blood-stream) infection secondary to urinary tract infection,
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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
April 1, 2003
Study Completion
July 1, 2006
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 7, 2005
First Posted (ESTIMATE)
September 12, 2005
Study Record Updates
Last Update Posted (ACTUAL)
October 26, 2018
Last Update Submitted That Met QC Criteria
October 25, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-24
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.