Urinary Tract InfectionsNCT01611519
Early or Late Foley Removal After Thoracotomy
An observational study of Urinary Tract Infections, run by Mayo Clinic at 1 site in United States.
Trial summary
Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery with an epidural catheter in place? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing thoracic surgery at the Mayo Clinic
Who may be able to join
- epidural catheter after thoracic surgery
- foley in place
Who cannot join
- < 18 years of age
- death in hospital within 30 days of the operation
- length of hospital stay is less than 48 hours
- epidural catheter is removed before the 3rd postoperative day
- patients who have a suprapubic catheter or no bladder
- patients who require a urologist or a urologic technician to insert the Foley catheter at the time of surgery
Show all 9Show fewer
- patients who were being intermittently catheterized before surgery
- patients with a known urinary tract infection preoperatively
- patients required to keep Foley in since they required close monitoring of urinary output
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Optimal Timing of Foley Catheter Removal in Patients Undergoing Thoracic Surgery With Epidural Analgesia: A Randomized, Controlled Trial
Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery with an epidural catheter in place?
Read the detailed description
We hypothesis that removing the foley catheter within 48 hours after a thoracotomy in patients that have an epidural catheter will result in an increase in the rate of urinary infections and the need for reinsertion of the foley. We have designed a randomized trial to test this hypothesis.
- Conditions
- Urinary Tract Infections
- Keywords
- urinary bladder, urinary catheterization, epidural analgesia, catheters, indwelling
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Early (within 48 hours of surgery) | Patients will have their urinary catheter removed within 48 hours of surgery | |
| Late (6 hours after epidural removal) | Patients will have their urinary catheter removed 6 hours after their epidural is removed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for insertion of catheter after Foley removed.
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes (1)
Development of urinary tract infection
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Allen, Mayo Clinic
- Investigators
- Mark Allen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611519
- Sponsor's protocol ID
- 11-006618
- Status last verified
- Sep 2016
- First submitted
- 1 Jun 2012
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
PubMed 34184246
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Foley Catheter Removal in Patients Undergoing Thoracic Surgery With Epidural Analgesia: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01611519
- Acronym / sponsor ID
- 11-006618
- Conditions
- Urinary Tract Infections
- Keywords
- urinary bladder, urinary catheterization, epidural analgesia, catheters, indwelling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery with an epidural catheter in place?
Detailed description
We hypothesis that removing the foley catheter within 48 hours after a thoracotomy in patients that have an epidural catheter will result in an increase in the rate of urinary infections and the need for reinsertion of the foley. We have designed a randomized trial to test this hypothesis.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early (within 48 hours of surgery) | – | –Patients will have their urinary catheter removed within 48 hours of surgery |
| Late (6 hours after epidural removal) | – | –Patients will have their urinary catheter removed 6 hours after their epidural is removed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing thoracic surgery at the Mayo Clinic
Key inclusion criteria (2 listed)
- epidural catheter after thoracic surgery
- foley in place
Key exclusion criteria (9 listed)
- < 18 years of age
- death in hospital within 30 days of the operation
- length of hospital stay is less than 48 hours
- epidural catheter is removed before the 3rd postoperative day
- patients who have a suprapubic catheter or no bladder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Need for insertion of catheter after Foley removed.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
1 secondary outcome
Development of urinary tract infection
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Derived from this study: PubMed 34184246Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
- Individual participant dataSharing planned: No
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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.
Mark Allen, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Mayo Clinic at 1 site in United States.
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 9 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 13 Sep 2016. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Need for insertion of catheter after Foley removed. (time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01611519, which also lists 1 linked publication.
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 13 Sep 2016.