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Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00672503
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : October 12, 2011
Sponsor:
Information provided by (Responsible Party):
Tangela Welch, Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date May 2, 2008
First Posted Date May 6, 2008
Last Update Posted Date October 12, 2011
Study Start Date May 2008
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2008)		 Identification of risk factors associated with indwelling urinary catheters. [ Time Frame: 2004-2007 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 5, 2008)		 Identification of nurses' knowledge of insertion, irrigation, care and maintenance of indwelling urinary catheters. [ Time Frame: 2008 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit
Official Title "Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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
Condition Urinary Tract Infections
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 7, 2011)		 321
Original Estimated Enrollment
 (submitted: May 5, 2008)		 218
Actual Study Completion Date October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Nurses employed at Children's Mercy Hospital in the PICU.
  4. Patient's who acquired a CA-UTI during 2009 and was adjudicated by infection control.

Exclusion Criteria:

Patients

  1. Patients with community acquired urinary tract infections
  2. Patients 18 years and older cared for in the PICU.
  3. Patients with catheter associated urinary tract infections hospitalized outside the PICU at Children's Mercy Hospital.
  4. Patients with UTI not related to catheterization

Nurses

  1. Nurses floated to the PICU who are not permanent staff members (ICN nurse, float pool staff, travelers)
  2. Nurses on the research team
Sex/Gender
Sexes Eligible for Study: All
Ages up to 17 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00672503
Other Study ID Numbers 08 04-065E
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tangela Welch, Children's Mercy Hospital Kansas City
Study Sponsor Children's Mercy Hospital Kansas City
Collaborators Not Provided
Investigators
Principal Investigator: Tangela M Welch, ADN, BBA Children's Mercy Hospital Kansas City
PRS Account Children's Mercy Hospital Kansas City
Verification Date October 2011