Urinary Tract InfectionPV-BUSNCT00847392
Study to Determine Pediatric Bladder Volume Prior to Catheterization
A study testing Ultrasound prior to bladder catheterization in people with Urinary Tract Infection, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
This is a randomized controlled trial evaluating the effectiveness of bedside volumetric bladder ultrasound prior to transurethral catheterization of pediatric patients presenting to an emergency department with suspected urinary tract infection. Read more about this study
- Who is it for?
- Ages Up to 36 months
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Ultrasound prior to bladder catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Jun 2009
- 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 Up to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 0-36 months of age
- Require urethral catheterization for urine analysis
Who cannot join
- Recently voided and unlikely to provide sufficient urine when catheterized
- Documented or suspected genitourinary abnormalities precluding urethral catheterization
- Indwelling catheter or urostomy
- Critical illness
- No available legal guardian or legal guardian does not understand English well enough to provide informed consent
- Technical failure of the utlrasound equipment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Volumetric Bladder Ultrasound Study
This is a randomized controlled trial evaluating the effectiveness of bedside volumetric bladder ultrasound prior to transurethral catheterization of pediatric patients presenting to an emergency department with suspected urinary tract infection.
Ultrasound prior to catheterization allows Emergency Physicians to determine if the urine volume of the bladder is sufficient for successful catheterization. Advance knowledge of insufficient urine allows the Emergency Physician to defer the procedure until success is likely.
- Conditions
- Urinary Tract Infection
- Being tested
- Ultrasound prior to bladder catheterization
- Keywords
- Urethral catheterization, Emergency Department, Ultrasound, Urinary tract infection, Pediatric
- Medical subject headings
- Urinary Tract Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound prior to bladder catheterizationProcedure or surgery
Bedside ultrasound to estimated volume of urine in bladder
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Bladder ultrasound prior to catheterization Receives: Procedure: Ultrasound prior to bladder catheterization |
| Standard catheterization | No intervention | No ultrasound prior to bladder catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients in each arm from whom at least 2 ml of urine is obtained on first attempt at catheterization.
Measured: First feasible attempt at catheterization during ED visit (minutes-hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Inability to obtain grant funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Investigators
- Andrew Worster, MD, MSc, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847392
- Sponsor's protocol ID
- PV-BUS
- Acronym
- PV-BUS
- Status last verified
- Sep 2016
- First submitted
- 17 Feb 2009
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Volumetric Bladder Ultrasound Study
- ClinicalTrials.gov ID
- NCT00847392
- Acronym / sponsor ID
- PV-BUS / PV-BUS
- Conditions
- Urinary Tract Infection
- Keywords
- Urethral catheterization, Emergency Department, Ultrasound, Urinary tract infection, Pediatric
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to obtain grant funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 19 Feb 2009 (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.
This is a randomized controlled trial evaluating the effectiveness of bedside volumetric bladder ultrasound prior to transurethral catheterization of pediatric patients presenting to an emergency department with suspected urinary tract infection.
Ultrasound prior to catheterization allows Emergency Physicians to determine if the urine volume of the bladder is sufficient for successful catheterization. Advance knowledge of insufficient urine allows the Emergency Physician to defer the procedure until success is likely.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Procedure: Ultrasound prior to bladder catheterizationBladder ultrasound prior to catheterization |
| Standard catheterization | No intervention | –No ultrasound prior to bladder catheterization |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 0-36 months of age
- Require urethral catheterization for urine analysis
Key exclusion criteria (6 listed)
- Recently voided and unlikely to provide sufficient urine when catheterized
- Documented or suspected genitourinary abnormalities precluding urethral catheterization
- Indwelling catheter or urostomy
- Critical illness
- No available legal guardian or legal guardian does not understand English well enough to provide informed consent
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 |
|---|---|---|
| Ultrasound prior to bladder catheterizationBedside ultrasound to estimated volume of urine in bladder | Procedure or surgery | Ultrasound |
Primary outcome
The proportion of patients in each arm from whom at least 2 ml of urine is obtained on first attempt at catheterization.
Time frame: First feasible attempt at catheterization during ED visit (minutes-hours).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
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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.
Andrew Worster, MD, MSc principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound prior to bladder catheterization in people with Urinary Tract Infection, run by Hamilton Health Sciences Corporation at 1 site 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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
The proportion of patients in each arm from whom at least 2 ml of urine is obtained on first attempt at catheterization. (time frame: First feasible attempt at catheterization during ED visit (minutes-hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2016.