Urinary Tract InfectionsNCT00672503
Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit
An observational study of Urinary Tract Infections, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 321 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
About this study
Official title: "Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit
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.
- Conditions
- Urinary Tract Infections
- Keywords
- indwelling urinary catheters, urinary tract infections, foley-catheter related infections, hospital acquired CA-UTI
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of risk factors associated with indwelling urinary catheters.
Measured: 2004-2007
Secondary outcomes (1)
Identification of nurses' knowledge of insertion, irrigation, care and maintenance of indwelling urinary catheters.
Measured: 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tangela Welch, Children's Mercy Hospital Kansas City
- Investigators
- Tangela M Welch, ADN, BBA, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672503
- Sponsor's protocol ID
- 08 04-065E
- Status last verified
- Oct 2011
- First submitted
- 2 May 2008
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Decreasing Catheter-Associated Urinary Tract Infections in the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00672503
- Acronym / sponsor ID
- 08 04-065E
- Conditions
- Urinary Tract Infections
- Keywords
- indwelling urinary catheters, urinary tract infections, foley-catheter related infections, hospital acquired CA-UTI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 6 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of risk factors associated with indwelling urinary catheters.
Time frame: 2004-2007
1 secondary outcome
Identification of nurses' knowledge of insertion, irrigation, care and maintenance of indwelling urinary catheters.
Time frame: 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tangela M Welch, ADN, BBA principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of risk factors associated with indwelling urinary catheters. (time frame: 2004-2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.