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CompletedNCT01067768Updated Mar 5, 2019Results posted

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

An interventional study of Daily review in Urinary Tract Infections and Urinary Tract; Accessory, sponsored by Hospital Pablo Tobón Uribe. Completed at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-05.

Sponsored by Hospital Pablo Tobón Uribe · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,209
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Urinary Tract Infections
  • Urinary Tract; Accessory

Keywords

  • Urinary Tract Infections
  • Catheter-associated urinary tract infections
  • Prevention and control
  • Controlled clinical trial
03

In context

Urinary Tract Infections

803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.

This study's enrollment of 1,209 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

Hospital Pablo Tobón Uribe is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Urinary tract infection diagnosis at time of the insertion
  • Spinal cord injury or neurogenic bladder at admission
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,209 participants (actual)

Study arms

  • 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

  • No intervention
    Routine care

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

Interventions

  • OtherDaily 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

    Also known as: Review for indication

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Catheter Days

    The duration of catheterization

    Time frame: withdrawal of the catheter

07

Results

Posted Aug 4, 2011

Participant flow

Adult patients hospitalized with indwelling urinary catheters at a tertiary care, 300-bed, teaching hospital in Colombia- South America, were recruitment between November 2009 and May 2010.

Participant flow — Overall Study
MilestoneDaily ReviewControl Group
Started604605
Completed604605
Not completed00

Outcome measures

PrimaryRate of Catheter-associated Urinary Tract Infection
Time frame:
Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)
Reported as:
Number · infections per 1000 days
Rate of Catheter-associated Urinary Tract Infection
infections per 1000 daysDaily ReviewControl Group
Rate of Catheter-associated Urinary Tract Infection10 (6.58 to 14.02)12 (8.85 to 16.34)
Statistical analysis
  • Daily Review vs Control Group · Risk ratio (rr): 0.81 · 95% CI 0.50 to 1.3The primary outcome analysis was performed using relative risk (RR) between the rate of urinary tract infection per 1,000 days of exposure of the test subjects to intervention and that of patients undergoing routine care.
SecondaryCatheter Days

The duration of catheterization

Time frame:
withdrawal of the catheter
Reported as:
Median · Days
Catheter Days
DaysDaily ReviewControl Group
Catheter Days2 (1 to 5)3 (1 to 6)
Statistical analysis
  • Daily Review vs Control Group · Wilcoxon (Mann-Whitney) · p = 0.016 (The difference between groups was evaluated with a U test Mann Whitney. The difference was statistically significant with p values less than 0.05)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Daily Review—0/604 (0%)0/604 (0%)
Control Group—0/605 (0%)0/605 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Daily ReviewControl GroupTotal
Median55 (38 to 69)56 (37 to 69)55.5 (37 to 69)
Sex: Female, Male
Sex: Female, Male(Participants)Daily ReviewControl GroupTotal
Female250253503
Male354352706
Diabetes
Diabetes(participants)Daily ReviewControl GroupTotal
Yes8884172
No5165211037
Kidney failure
Kidney failure(participants)Daily ReviewControl GroupTotal
Yes10494198
No5005111011
Indication of catheter
Indication of catheter(participants)Daily ReviewControl GroupTotal
Obstruction281947
Incontinence303
Monitoring268269537
Procedures303316619
None213
Unit placement
Unit placement(participants)Daily ReviewControl GroupTotal
Emergency175167342
Critical care6767134
Surgery271282553
General room342458
Before admission494998
Another81624
08

Study locations

1 site
  • Hospital Pablo Tobon Uribe
    Medellin, Antioquia, Colombia
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01067768
Lead sponsor
Hospital Pablo Tobón Uribe
Responsible party
Maria Victoria Restrepo (MD, MSc, Hospital Pablo Tobón Uribe) — Principal investigator
First posted
Feb 12, 2010
Start date
Nov 2009
Primary completion
Sep 2010
Completion
Sep 2010
Results posted
Aug 4, 2011
Last update
Mar 5, 2019

Study contacts

María V Restrepo, Dr.
principal investigator · Hospital Pablo Tobón Uribe

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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