NCT01067768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 4, 2011

Completed
Last Updated

March 5, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

February 10, 2010

Results QC Date

July 11, 2011

Last Update Submit

February 21, 2019

Conditions

Keywords

Urinary Tract InfectionsCatheter-associated urinary tract infectionsPrevention and controlControlled clinical trial

Outcome Measures

Primary Outcomes (1)

  • Rate of Catheter-associated Urinary Tract Infection

    Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)

Secondary Outcomes (1)

  • Catheter Days

    withdrawal of the catheter

Study Arms (2)

Daily review

EXPERIMENTAL

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

Routine care

NO INTERVENTION

In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.

Interventions

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

Also known as: Review for indication
Daily review

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatient with a permanent urinary catheter (balloon catheter)
  • Urinary catheter placed in the hospitalization (previous day) or at admission

You may not qualify if:

  • Urinary tract infection diagnosis at time of the insertion
  • Spinal cord injury or neurogenic bladder at admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Dr. María Victoria Restrepo
Organization
Hospital Pablo Tobón Uribe

Study Officials

  • María V Restrepo, Dr.

    Hospital Pablo Tobón Uribe

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 12, 2010

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

March 5, 2019

Results First Posted

August 4, 2011

Record last verified: 2019-02

Locations