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Automatic Stop Orders for Urinary Catheters

Primary Purpose

Urinary Tract Infections

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Automatic stop order

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring urinary infections, catheters, bacteriuria, trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Urinary catheter for less than 48hrs Exclusion Criteria: Patient with symptomatic urinary tract infection Latex allergy

Sites / Locations

McMaster University Medical Centre
Henderson Hospital
Hamilton General Hospital

Outcomes

Primary Outcome Measures

Urinary tract infections

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00157625

First Posted

September 7, 2005

Last Updated

October 25, 2018

Sponsor

McMaster University

Collaborators

The Physicians' Services Incorporated Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00157625

Brief Title

Automatic Stop Orders for Urinary Catheters

Official Title

A Randomized Controlled Trial of Automatic Stop Orders for Urinary Catheterization in Hospitalized Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

McMaster University

Collaborators

The Physicians' Services Incorporated Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infections

Keywords

urinary infections, catheters, bacteriuria, trial

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

630 (false)

8. Arms, Groups, and Interventions

Intervention Type

Behavioral

Intervention Name(s)

Automatic stop order

Primary Outcome Measure Information:

Title

Urinary tract infections

Secondary Outcome Measure Information:

Title

days of indwelling urinary catheterization,

Title

symptomatic urinary tract infection,

Title

isolation of antimicrobial-resistant bacteria from catheterized urine,

Title

antimicrobial use,

Title

bacteremia (blood-stream) infection secondary to urinary tract infection,

Title

cost

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Urinary catheter for less than 48hrs Exclusion Criteria: Patient with symptomatic urinary tract infection Latex allergy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark B Loeb, MD MSc FRCPC

Organizational Affiliation

McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

McMaster University Medical Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3z5

Country

Canada

Facility Name

Henderson Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 1C3

Country

Canada

Facility Name

Hamilton General Hospital

City

Hamilton

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

34184246

Citation

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.

Results Reference

derived

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Automatic Stop Orders for Urinary Catheters

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