NCT00672503

Brief Summary

The purpose of this study is to identify risk factors associated with indwelling urinary catheters, as well as to assess the nurses' knowledge and adherence to hospital policies. The study will also include a very extensive literature search in an attempt to create a national standard or guideline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 2, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 12, 2011

Status Verified

October 1, 2011

Enrollment Period

3.4 years

First QC Date

May 2, 2008

Last Update Submit

October 7, 2011

Conditions

Keywords

indwelling urinary cathetersurinary tract infectionsfoley-catheter related infectionshospital acquired CA-UTI

Outcome Measures

Primary Outcomes (1)

  • Identification of risk factors associated with indwelling urinary catheters.

    2004-2007

Secondary Outcomes (1)

  • Identification of nurses' knowledge of insertion, irrigation, care and maintenance of indwelling urinary catheters.

    2008

Study Arms (4)

1

Patients who acquired a CA-UTI in the PICU between 2004-2007.

2

Patients who did not acquire a CA-UTI while hospitalized in the PICU but had an indwelling urinary catheter between 2004-2007.

A

Nurses currently employed in the PICU at Children's Mercy Hospital.

a

Root Cause Analysis on all patients who acquired a CA-UTI during 2009.

Eligibility Criteria

Age1 Day - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

1. Patients who acquired a CA-UTI while hospitalized in the PICU between 2004-2007. 2. Patients who had an indwelling urinary catheter while hospitalized in the PICU between 2004-2007 but did not acquire a CA-UTI. 3. Nurses currently employed in the PICU at Children's Mercy Hospital. 4. All Patient's who acquired a CA-UTI during 2009

You may qualify if:

  • Medical records of 67 patients 0 to 17 years of age diagnosed with a catheter associated urinary tract infection (defined by CDC) acquired during a PICU hospitalization.
  • Medical records of 67 patients 0 to 17 years of age who had an indwelling urinary catheter during a PICU hospitalization without a catheter associated urinary tract infection.
  • Nurses employed at Children's Mercy Hospital in the PICU.
  • Patient's who acquired a CA-UTI during 2009 and was adjudicated by infection control.

You may not qualify if:

  • Patients
  • Patients with community acquired urinary tract infections
  • Patients 18 years and older cared for in the PICU.
  • Patients with catheter associated urinary tract infections hospitalized outside the PICU at Children's Mercy Hospital.
  • Patients with UTI not related to catheterization
  • Nurses
  • Nurses floated to the PICU who are not permanent staff members (ICN nurse, float pool staff, travelers)
  • Nurses on the research team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Tangela M Welch, ADN, BBA

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PICU Clinical Research Coordinator

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 6, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 12, 2011

Record last verified: 2011-10

Locations