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

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. Identifier: NCT01067768
Recruitment Status : Completed
First Posted : February 12, 2010
Results First Posted : August 4, 2011
Last Update Posted : March 28, 2014
Information provided by (Responsible Party):
Maria Victoria Restrepo, Hospital Pablo Tobón Uribe

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Urinary Tract; Accessory Other: Daily review Phase 3

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  (Clinical Trial)
Actual Enrollment : 1209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication. Randomized Controlled Trial
Study Start Date : November 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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.

Primary Outcome Measures :
  1. 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 Measures :
  1. Catheter Days [ Time Frame: withdrawal of the catheter ]
    The duration of catheterization

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01067768

Hospital Pablo Tobon Uribe
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Hospital Pablo Tobón Uribe
Principal Investigator: María V Restrepo, Dr. Hospital Pablo Tobón Uribe

Responsible Party: Maria Victoria Restrepo, MD, MSc, Hospital Pablo Tobón Uribe Identifier: NCT01067768     History of Changes
Other Study ID Numbers: 5100-66592
First Posted: February 12, 2010    Key Record Dates
Results First Posted: August 4, 2011
Last Update Posted: March 28, 2014
Last Verified: March 2014

Keywords provided by Maria Victoria Restrepo, Hospital Pablo Tobón Uribe:
Urinary Tract Infections
Catheter-associated urinary tract infections
Prevention and control
Controlled clinical trial

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urologic Diseases