Study to Determine Pediatric Bladder Volume Prior to Cath... | NCT00847392

Studies
Study to Determine Pediatric Bladder Volume Prior to Catheterization

NCT00847392

Sponsor

Hamilton Health Sciences Corporation

Status

Withdrawn

Last Update Posted

Sep 19, 2016Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Urinary Tract Infection

Interventions

Ultrasound prior to bladder catheterization

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inability to obtain grant funding

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Feb 17, 2009

First Submission Date that Met QC Criteria

Feb 17, 2009

First Posted Date

Feb 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2016

Last Update Posted Date

Sep 19, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrasound	Experimental	Bladder ultrasound prior to catheterization	Procedure: Ultrasound prior to bladder catheterization
Standard catheterization	No Intervention	No ultrasound prior to bladder catheterization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound prior to bladder catheterization	Procedure	Bedside ultrasound to estimated volume of urine in bladder	Ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of patients in each arm from whom at least 2 ml of urine is obtained on first attempt at catheterization.		First feasible attempt at catheterization during ED visit (minutes-hours).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

36 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Worster, MD, MSc	Hamilton Health Sciences Corporation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton Health Sciences		Hamilton	Ontario	L5G4T8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections
D004630	Emergencies

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided