Trial Outcomes & Findings for Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication (NCT NCT01067768)
NCT ID: NCT01067768
Last Updated: 2019-03-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1209 participants
Primary outcome timeframe
Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)
Results posted on
2019-03-05
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.
1.325 patients were assessed for eligibility. 143 were excluded (98 urinary infection and 45 spinal cord injury).
Participant milestones
| Measure |
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.
|
Control Group
In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
604
|
605
|
|
Overall Study
COMPLETED
|
604
|
605
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication
Baseline characteristics by cohort
| Measure |
Daily Review
n=604 Participants
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.
|
Control Group
n=605 Participants
In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
|
Total
n=1209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 years
n=99 Participants
|
56 years
n=107 Participants
|
55.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
250 Participants
n=99 Participants
|
253 Participants
n=107 Participants
|
503 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
354 Participants
n=99 Participants
|
352 Participants
n=107 Participants
|
706 Participants
n=206 Participants
|
|
Diabetes
Yes
|
88 participants
n=99 Participants
|
84 participants
n=107 Participants
|
172 participants
n=206 Participants
|
|
Diabetes
No
|
516 participants
n=99 Participants
|
521 participants
n=107 Participants
|
1037 participants
n=206 Participants
|
|
Kidney failure
Yes
|
104 participants
n=99 Participants
|
94 participants
n=107 Participants
|
198 participants
n=206 Participants
|
|
Kidney failure
No
|
500 participants
n=99 Participants
|
511 participants
n=107 Participants
|
1011 participants
n=206 Participants
|
|
Indication of catheter
Obstruction
|
28 participants
n=99 Participants
|
19 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Indication of catheter
Incontinence
|
3 participants
n=99 Participants
|
0 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Indication of catheter
Monitoring
|
268 participants
n=99 Participants
|
269 participants
n=107 Participants
|
537 participants
n=206 Participants
|
|
Indication of catheter
Procedures
|
303 participants
n=99 Participants
|
316 participants
n=107 Participants
|
619 participants
n=206 Participants
|
|
Indication of catheter
None
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Unit placement
Emergency
|
175 participants
n=99 Participants
|
167 participants
n=107 Participants
|
342 participants
n=206 Participants
|
|
Unit placement
Critical care
|
67 participants
n=99 Participants
|
67 participants
n=107 Participants
|
134 participants
n=206 Participants
|
|
Unit placement
Surgery
|
271 participants
n=99 Participants
|
282 participants
n=107 Participants
|
553 participants
n=206 Participants
|
|
Unit placement
General room
|
34 participants
n=99 Participants
|
24 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
Unit placement
Before admission
|
49 participants
n=99 Participants
|
49 participants
n=107 Participants
|
98 participants
n=206 Participants
|
|
Unit placement
Another
|
8 participants
n=99 Participants
|
16 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)Population: Analysis by intention to treat
Outcome measures
| Measure |
Daily Review
n=604 Participants
Daily monitoring of catheter indication
|
Control Group
n=605 Participants
In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
|
|---|---|---|
|
Rate of Catheter-associated Urinary Tract Infection
|
10 infections per 1000 days
Interval 6.58 to 14.02
|
12 infections per 1000 days
Interval 8.85 to 16.34
|
SECONDARY outcome
Timeframe: withdrawal of the catheterPopulation: Analysis by intention to treat
The duration of catheterization
Outcome measures
| Measure |
Daily Review
n=604 Participants
Daily monitoring of catheter indication
|
Control Group
n=605 Participants
In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
|
|---|---|---|
|
Catheter Days
|
2 Days
Interval 1.0 to 5.0
|
3 Days
Interval 1.0 to 6.0
|
Adverse Events
Daily Review
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place