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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Victoria Restrepo, Hospital Pablo Tobón Uribe
ClinicalTrials.gov Identifier:
NCT01067768
First received: February 10, 2010
Last updated: March 2, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Urinary Tract Infections
Urinary Tract; Accessory
Other: Daily review
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hospital Pablo Tobón Uribe:

Primary Outcome Measures:
  • Rate of Catheter-associated Urinary Tract Infection [ Time Frame: Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Catheter Days [ Time Frame: withdrawal of the catheter ] [ Designated as safety issue: No ]
    The duration of catheterization


Enrollment: 1209
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067768

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

No publications provided

Responsible Party: Maria Victoria Restrepo, MD, MSc, Hospital Pablo Tobón Uribe
ClinicalTrials.gov Identifier: NCT01067768     History of Changes
Other Study ID Numbers: 5100-66592
Study First Received: February 10, 2010
Results First Received: July 11, 2011
Last Updated: March 2, 2014
Health Authority: Colombia: Institutional Review Board

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

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on July 28, 2014