Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication

February 21, 2019 updated by: Maria Victoria Restrepo, Hospital Pablo Tobón Uribe

Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication. Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1209

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Hospital Pablo Tobón Uribe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Daily review
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.
Other: Daily review

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

Other Names:
  • Review for indication
NO_INTERVENTION: Routine care
In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Catheter-associated Urinary Tract Infection
Time Frame: Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)
Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter Days
Time Frame: withdrawal of the catheter
The duration of catheterization
withdrawal of the catheter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Pablo Tobón Uribe

Investigators

  • Principal Investigator: María V Restrepo, Dr., Hospital Pablo Tobón Uribe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

February 10, 2010

First Submitted That Met QC Criteria

February 10, 2010

First Posted (ESTIMATE)

February 12, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5100-66592

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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