Urinary Tract; Accessory, Urinary Tract Infections
Conditions
Keywords
Urinary Tract Infections, Catheter-associated urinary tract infections, Prevention and control, Controlled clinical trial
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.
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.
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
Sponsors
Hospital Pablo Tobón Uribe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of Catheter-associated Urinary Tract Infection | Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catheter Days | withdrawal of the catheter | The duration of catheterization |
Countries
Colombia
Participant flow
Recruitment details
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.
Pre-assignment details
1.325 patients were assessed for eligibility. 143 were excluded (98 urinary infection and 45 spinal cord injury).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 604 |
| Control Group In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol. | 605 |
| Total | 1,209 |
Baseline characteristics
| Characteristic | Daily Review | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 55 years | 55.5 years | 56 years |
| Diabetes No | 516 participants | 1037 participants | 521 participants |
| Diabetes Yes | 88 participants | 172 participants | 84 participants |
| Indication of catheter Incontinence | 3 participants | 3 participants | 0 participants |
| Indication of catheter Monitoring | 268 participants | 537 participants | 269 participants |
| Indication of catheter None | 2 participants | 3 participants | 1 participants |
| Indication of catheter Obstruction | 28 participants | 47 participants | 19 participants |
| Indication of catheter Procedures | 303 participants | 619 participants | 316 participants |
| Kidney failure No | 500 participants | 1011 participants | 511 participants |
| Kidney failure Yes | 104 participants | 198 participants | 94 participants |
| Sex: Female, Male Female | 250 Participants | 503 Participants | 253 Participants |
| Sex: Female, Male Male | 354 Participants | 706 Participants | 352 Participants |
| Unit placement Another | 8 participants | 24 participants | 16 participants |
| Unit placement Before admission | 49 participants | 98 participants | 49 participants |
| Unit placement Critical care | 67 participants | 134 participants | 67 participants |
| Unit placement Emergency | 175 participants | 342 participants | 167 participants |
| Unit placement General room | 34 participants | 58 participants | 24 participants |
| Unit placement Surgery | 271 participants | 553 participants | 282 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 604 | 0 / 605 |
| serious Total, serious adverse events | 0 / 604 | 0 / 605 |
Outcome results
Primary
Rate of Catheter-associated Urinary Tract Infection
Time frame: Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)
Population: Analysis by intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daily Review | Rate of Catheter-associated Urinary Tract Infection | 10 infections per 1000 days |
| Control Group | Rate of Catheter-associated Urinary Tract Infection | 12 infections per 1000 days |
Comparison: The sample size was calculated for the primary outcome. An infection rate 15 per 1,000 urinary catheter days in the control group and an expected reduction in the intervention group 40% clinically important effect. Mapping one to one, 5% alpha error and beta error 20%.95% CI: [0.5, 1.3]
Secondary
Catheter Days
The duration of catheterization
Time frame: withdrawal of the catheter
Population: Analysis by intention to treat
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Daily Review | Catheter Days | 2 Days |
| Control Group | Catheter Days | 3 Days |
Comparison: Null hypothesis: On average catheterization are the same in patients with daily review of the indication and control group patientsp-value: 0.016Wilcoxon (Mann-Whitney)