Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication
Primary Purpose
Urinary Tract Infections, Urinary Tract; Accessory
Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Daily review
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infections focused on measuring Urinary Tract Infections, Catheter-associated urinary tract infections, Prevention and control, Controlled clinical trial
Eligibility Criteria
Inclusion Criteria:
- Inpatient with a permanent urinary catheter (balloon catheter)
- Urinary catheter placed in the hospitalization (previous day) or at admission
Exclusion Criteria:
- Urinary tract infection diagnosis at time of the insertion
- Spinal cord injury or neurogenic bladder at admission
Sites / Locations
- Hospital Pablo Tobon Uribe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Daily review
Routine care
Arm Description
In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
Outcomes
Primary Outcome Measures
Rate of Catheter-associated Urinary Tract Infection
Secondary Outcome Measures
Catheter Days
The duration of catheterization
Full Information
NCT ID
NCT01067768
First Posted
February 10, 2010
Last Updated
February 21, 2019
Sponsor
Hospital Pablo Tobón Uribe
1. Study Identification
Unique Protocol Identification Number
NCT01067768
Brief Title
Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication
Official Title
Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication. Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Pablo Tobón Uribe
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether the daily nurse review of the indication of the urinary catheter compared to the everyday care of the working staff is effective to reduce the rate of catheter-associated urinary tract infection in adults hospitalized.
Detailed Description
Healthcare-associated infection (HAI)in hospitalized patients are very frequent, especially the catheter-associated urinary tract infection, which prolongs the hospital stay and costs, and is about 3 times more likely to die during hospitalization than patients not infected.
The measures of aseptic insertion and closed systems of collection, as well as the rational use of the probe reduce the risk for infection.
A checklist that contains the agreed indications of catheter, related to obstruction, incontinence, skin lesions in sacral region, monitoring or surgical procedures allows the daily review of the indication of the probe. If the patient doesn´t meet at least one of the criteria, should be recommended the withdrawal of the catheter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Urinary Tract; Accessory
Keywords
Urinary Tract Infections, Catheter-associated urinary tract infections, Prevention and control, Controlled clinical trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1209 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daily review
Arm Type
Experimental
Arm Description
In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
Intervention Type
Other
Intervention Name(s)
Daily review
Other Intervention Name(s)
Review for indication
Intervention Description
Daily nursing review of the urinary catheter´s indication. If the patient meets at least one of the entries to stay with bladder catheter, the nurse will record collection in the format but will not contact the health team. If there aren´t indication in the medical record, she contacts at the attending physician and said: "Doctor, I didn´t find record in the history of the indication of the urinary catheter, can we withdraw?. If the physician reported the indication, will be recorded in the format without additional comments.
The attending physician decides withdraw or no withdraw the urinary catheter
Primary Outcome Measure Information:
Title
Rate of Catheter-associated Urinary Tract Infection
Time Frame
Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)
Secondary Outcome Measure Information:
Title
Catheter Days
Description
The duration of catheterization
Time Frame
withdrawal of the catheter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inpatient with a permanent urinary catheter (balloon catheter)
Urinary catheter placed in the hospitalization (previous day) or at admission
Exclusion Criteria:
Urinary tract infection diagnosis at time of the insertion
Spinal cord injury or neurogenic bladder at admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
María V Restrepo, Dr.
Organizational Affiliation
Hospital Pablo Tobón Uribe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
State/Province
Antioquia
Country
Colombia
12. IPD Sharing Statement
Learn more about this trial
Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication
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