Urinary Tract InfectionsNCT01067768
Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication
A study testing Daily review in people with Urinary Tract Infections and Urinary Tract; Accessory, run by Hospital Pablo Tobón Uribe at 1 site in Colombia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections, Urinary Tract; Accessory
- What is being tested?
- Daily review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,209 participants
- Where
- 1 siteColombia
- Study dates
- Nov 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient with a permanent urinary catheter (balloon catheter)
- Urinary catheter placed in the hospitalization (previous day) or at admission
Who cannot join
- Urinary tract infection diagnosis at time of the insertion
- Spinal cord injury or neurogenic bladder at admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication. Randomized Controlled Trial
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.
- Conditions
- Urinary Tract Infections, Urinary Tract; Accessory
- Being tested
- Daily review
- Keywords
- Urinary Tract Infections, Catheter-associated urinary tract infections, Prevention and control, Controlled clinical trial
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily reviewOther
Also called Review for indication
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Catheter-associated Urinary Tract Infection
Measured: Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)
Secondary outcomes (1)
Catheter Days
The duration of catheterization
Measured: withdrawal of the catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Pablo Tobón Uribe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Victoria Restrepo, Hospital Pablo Tobón Uribe
- Investigators
- María V Restrepo, Dr., Principal investigator, Hospital Pablo Tobón Uribe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067768
- Sponsor's protocol ID
- 5100-66592
- Status last verified
- Feb 2019
- First submitted
- 10 Feb 2010
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Catheter-associated Urinary Tract Infection With a Daily Nursing Review of the Indication. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01067768
- Acronym / sponsor ID
- 5100-66592
- Conditions
- Urinary Tract Infections, Urinary Tract; Accessory
- Keywords
- Urinary Tract Infections, Catheter-associated urinary tract infections, Prevention and control, Controlled clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,209 participants (actual)
- Lead sponsor
- Hospital Pablo Tobón UribeUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Posted 4 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily review | Experimental | Other: Daily reviewIn 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. |
| Routine care | No intervention | –In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inpatient with a permanent urinary catheter (balloon catheter)
- Urinary catheter placed in the hospitalization (previous day) or at admission
Key exclusion criteria (2 listed)
- Urinary tract infection diagnosis at time of the insertion
- Spinal cord injury or neurogenic bladder at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily reviewAlso: Review for indicationDaily 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 | Daily review |
Primary outcome
Rate of Catheter-associated Urinary Tract Infection
Time frame: Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)
1 secondary outcome
Catheter Days
Time frame: withdrawal of the catheter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María V Restrepo, Dr. principal investigator
Hospital Pablo Tobón Uribe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily review in people with Urinary Tract Infections and Urinary Tract; Accessory, run by Hospital Pablo Tobón Uribe at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Catheter-associated Urinary Tract Infection (time frame: Until 7 days after the withdrawal of the catheter or at discharge (whichever comes first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.