Automatic Stop Orders for Urinary Catheters | NCT00157625

Studies
Automatic Stop Orders for Urinary Catheters

NCT00157625

Sponsor

McMaster University

Status

Completed

Last Update Posted

Oct 26, 2018Actual

Enrollment

630

Phase

Not Applicable

Conditions

Urinary Tract Infections

Interventions

Automatic stop order

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

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Jul 2006

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 12, 2005Estimated

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

Oct 25, 2018

Last Update Posted Date

Oct 26, 2018Actual

Name	Class
The Physicians' Services Incorporated Foundation	OTHER

Description Module

Brief 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. 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.

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

630

Name	Type	Description	Arm Group Labels	Other Names
Automatic stop order	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urinary tract infections

Secondary Outcomes

Measure	Description	Time Frame
days of indwelling urinary catheterization,
symptomatic urinary tract infection,
isolation of antimicrobial-resistant bacteria from catheterized urine,

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Urinary catheter for less than 48hrs

Exclusion Criteria:

Patient with symptomatic urinary tract infection
Latex allergy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark B Loeb, MD MSc FRCPC	McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McMaster University Medical Centre		Hamilton	Ontario	L8N 3z5	Canada
Henderson Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34184246	Derived	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.

ID	Term
D014552	Urinary Tract Infections
D001437	Bacteriuria

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