Study to Determine Pediatric Bladder Volume Prior to Catheterization (PV-BUS)

This study has been withdrawn prior to enrollment.
(Inability to obtain grant funding)
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00847392
First received: February 17, 2009
Last updated: June 24, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Urinary Tract Infection
Procedure: Ultrasound prior to bladder catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pediatric Volumetric Bladder Ultrasound Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound
Bladder ultrasound prior to catheterization
Procedure: Ultrasound prior to bladder catheterization
Bedside ultrasound to estimated volume of urine in bladder
No Intervention: Standard catheterization
No ultrasound prior to bladder catheterization

  Eligibility

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 0-36 months of age
  • Require urethral catheterization for urine analysis

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847392

Locations
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L5G4T8
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Andrew Worster, MD, MSc Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: Dr. Andrew Worster, Hamilton Health Sciences
ClinicalTrials.gov Identifier: NCT00847392     History of Changes
Other Study ID Numbers: PV-BUS
Study First Received: February 17, 2009
Last Updated: June 24, 2009
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by McMaster University:
Urethral catheterization
Emergency Department
Ultrasound
Urinary tract infection
Pediatric

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014