Urinary Tract InfectionsNCT00157625
Automatic Stop Orders for Urinary Catheters
A study testing Automatic stop order in people with Urinary Tract Infections, run by McMaster University at 3 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Automatic stop order
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 630 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2003to Jul 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urinary catheter for less than 48hrs
Who cannot join
- Patient with symptomatic urinary tract infection
- Latex allergy
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McMaster University Medical Centre
Hamilton, Ontario, L8N 3z5
Henderson Hospital
Hamilton, Ontario, L8V 1C3
Hamilton General Hospital
Hamilton, Ontario
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Tract Infections
- Being tested
- Automatic stop order
- Keywords
- urinary infections, catheters, bacteriuria, trial
- Medical subject headings
- Urinary Tract Infections, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic stop orderBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract infections
Secondary outcomes (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 630 participants
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Mark B Loeb, MD MSc FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157625
- Sponsor's protocol ID
- 03-24
- Status last verified
- Oct 2018
- First submitted
- 7 Sep 2005
- Last updated
- 26 Oct 2018
- Results posted
- No
Publications
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
PubMed 34184246
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Automatic Stop Orders for Urinary Catheterization in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT00157625
- Acronym / sponsor ID
- 03-24
- Conditions
- Urinary Tract Infections
- Keywords
- urinary infections, catheters, bacteriuria, trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Apr 2003
- Study completion
- Jul 2006
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Urinary catheter for less than 48hrs
Key exclusion criteria (2 listed)
- Patient with symptomatic urinary tract infection
- Latex allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic stop order | Behavioural | – |
Primary outcome
Urinary tract infections
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Derived from this study: PubMed 34184246Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark B Loeb, MD MSc FRCPC principal investigator
McMaster University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic stop order in people with Urinary Tract Infections, run by McMaster University at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract infections. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00157625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.