Urinary Tract InfectionNCT06896643
Urinary Infection and Colonization in Bone Procedures
An observational study of Urinary Tract Infection and Complications, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.
Trial summary
For seniors aged 65 and over (inclusive) undergoing surgical procedures (bone surgery, traumatology, orthopedics) in an acute or elective setting, the relationship between preoperative urinary tract infection/colonization (within 30 days before the procedure) and the occurrence of predefined postoperative… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Urinary Tract Infection, Complications, Urinary Tract Infection (Diagnosis)
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: For seniors over 65 years (including), undergoing surgery (bone procedure, traumatology, orthopedics) in an acute or elective mode, the relationship between preoperative infection/colonization of the urinary tract (within 30 days before the procedure) and the occurrence of predefined postoperative complications will be monitored.
Who may be able to join
- Age over 65 years, including
- Elective or acute trauma/orthopedic bone surgery
- Urine examination as part of pre-anesthetic examination, urine + sediment, in case of suspicion - bacteriological examination
- Signed informed consent for research as part of pre-anesthetic examination (I or II), respecting informed consent as an expression of the patient's "free will"
Who cannot join
- Negative finding in urine: chemical examination + sediment preoperatively
- Respondent under the influence of premedication, alcohol, or drugs
- Sensory impairment (blindness)
- Delirious preoperative state
- Severe mental disorder
- Sopor
Show all 10Show fewer
- coma
- Septic state
- Acute respiratory failure
- Disagreement with participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Tomas Bata Hospital
Zlín, 76001
Klára Nekvindová, M.D., Ph.D., +420 577 551 111, nekvindova.klara@gmail.com
Tomáš Gabrhelík, doc., M.D., Ph.D., + 420 577 552 280, Tomas.Gabrhelik@bnzlin.cz
About this study
For seniors aged 65 and over (inclusive) undergoing surgical procedures (bone surgery, traumatology, orthopedics) in an acute or elective setting, the relationship between preoperative urinary tract infection/colonization (within 30 days before the procedure) and the occurrence of predefined postoperative complications (monitoring during the patients' hospitalization) will be observed
Read the detailed description
For seniors aged 65 and over (inclusive) undergoing surgical procedures (bone surgery, traumatology, orthopedics) in an acute or elective setting, the relationship between preoperative urinary tract infection/colonization (within 30 days before the procedure) and the occurrence of predefined postoperative complications (monitoring during the patients' hospitalization) will be observed Among the monitored parameters before the surgical procedure will be urine collection (chemical + sediment - a common part of the pre-anesthetic examination), and in case of findings, a sample for bacteriological examination will be indicated. Additionally, subjective symptoms (present, absent), presence of fever, whether the infection/finding in the urine was treated or not, and whether a control urine examination was performed (performed, not performed) will be recorded. The origin of the patient (home, social care facility) and the planned surgical procedure will be noted. The Clinical Frailty Scale, type of anesthesia (general, regional), and any administered antibiotic treatment will also be recorded.
After the surgical procedure, the occurrence of urinary infection (yes, no, sample not taken) will be assessed. Postoperative complications such as fever, circulatory instability, development of delirium, infection, septic state, and death will be monitored. The trajectory of the respondent during hospitalization (which departments they will be treated in, including the length of hospitalization) will be recorded. The primary goal will be to determine the relationship between the preoperative occurrence of urinary infection or colonization in patients within the last 30 days before the procedure and the occurrence of predefined postoperative complications. Secondary goals will include identifying the most common postoperative complications in patients with preoperative urinary colonization or proven urinary infection. Additionally, the relationship between the preoperative Clinical Frailty Scale in the defined patient population and the occurrence of predefined postoperative complications will be examined. The final secondary goal will be to determine preoperative antibiotic therapy in the preoperative period.
The cohort of traumatology patients undergoing surgical procedures was chosen to ensure the homogeneity of the studied population (seniors over 65 undergoing bone surgery).
- Keywords
- urinary, tract, infection, colonization, postoperative complications
- Medical subject headings
- Urinary Tract Infections, Disease, Frailty, Infections, Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract infection preoperatively - signs and symptoms
Signs and symptoms include dysuria, frequency, urgency, or/and fever or/and smelling urine and non-specific signs (nausea, malaise)
Measured: one week before surgery
Urinary tract infection preoperatively - urinary dipstick test.
Positive urine dipstict test (i.e. nitrate-reductace and leukocyte esterase detection).
Measured: one week before surgery
Urinary tract infection preoperatively - chemical examination of the urine and sediment - pH
Positive result in chemical examination of the urine and the sediment for the possibility of infection s: pH ≥ 6.
Measured: one week before surgery
Urinary tract infection preoperatively: chemical examination - proteinuria (urine dipstick test)
Detection of proteinuria with urine dipstick test.
Measured: one week before surgery
Urinary tract infection preoperatively - leukocytouria (urine dipstick test)
Positive result t is leukocyturia (detection of leucocyte esteras) in a dipstick test.
Measured: one week before surgery
Urinary tract infection preoperatively chemical examination of the urine and sediment -pyuria (urine dipstick test)
Pyuria, which is the presence of white blood cells in the urine, will detected through these methods: Postive urine dipstick test - showing leukocyte esterase or nitrites.
And additionally have to present: discoloration, clouding or change in the smell of urine for a pyuria
Measured: one week before surgery
Urinary tract infection preoperatively: chemical examination of the urine and sediment -bacteriuria (urine dipstick test)
Presence of bacteriuria (presence of bacteria in the urine). Can be detected through urine dipstick test (determination of presence of leukocyte esterase and nitrites, which are indicators of white blood cells and bacteria in the urine)
Measured: one week before surgery
Urinary tract infection preoperatively - chemical examination preoperatively - chemical examination of the urine and sediment -bacteriuria
Presence of bacteriuria (presence of bacteria in the urine). Can be detected through through flow cytometry (this method detects bacteria in urinary samples in the range from 40 up to 1000/μl),
Measured: one week before surgery
Urinary tract infection preoperatively: chemical examination of the urine and sediment -bacteriuria (urine culture)
Presence of bacteriuria (presence of bacteria in the urine). Can be detected through urine culture (bacteria grow from a urine sample, cutoff is for a significant bacterial count is typically greater than 100,000 colony-forming units (CFU) per mililiter).
Measured: one week before surgery
Urinary tract infection preoperatively - chemical examination preoperatively - chemical examination of the urine and sediment - proteinuria
Detection of proteinuria with the sulfosalicylic acid test in laboratory.
A semiquantitative scale is used for evaluation:
- Opalescence - approximate concentration of protein in g/l: 0,05-0,1
- Slight turbidity (transparent, underlying text can be read - approximate concentration of protein in g/l: 0,1-0,2
- Milky turbidity (opaque, without flakes) - approximate concentration of protein in g/l: 0,5-1,0
- Milky turbidity with flake formation: approximate concentration of protein in g/l: 2,0-5,0
- Flocculent precipitate: approximate concentration of protein in g/l ≥ 5,0
Measured: one week before surgery
Urinary tract infection preoperatively - leukocytouria (sediment)
Positive result is finding in the in sediment more than 10 leukocytes per field of view.
Measured: one week before surgery
Urinary tract infection preoperatively chemical examination of the urine and sediment -pyuria (microscopy)
Pyuria, which is the presence of white blood cells in the urine, will detected through these methods: Microscopy - cell counts performer by microscopy, positive finding is more than 10 leukocytes per field of view.
And additionally have to present: discoloration, clouding or change in the smell of urine for a pyuria.
Measured: one week before surgery
Urinary tract colonization preoperatively - asymptomatic bacteriuria, women (urine culture)
Midstream clean catch urine specimen will be needed. Two consecutive specimens with isolation of the same bacteria species with at least 100,000 colony-forming units (CFUs) per ml of urine.
Measured: one week before surgery
Urinary tract colonization preoperatively - asymptomatic bacteriuria, men (urine culture)
Midstream clean catch urine specimen will be needed. For men, a single specimen with isolation of one bacteria species with at least 100,000 CFUs per ml of urine.
Measured: one week before surgery
Urinary tract colonization preoperatively - asymptomatic bacteriuria, catheterized specimen (urine culture))
For women or men, a single specimen with isolation of one bacteria species with at least 100 CFUs per ml of urine.
Measured: one week before surgery
Antibiotic therapy before the surgery
Preoperative antibiotic use will be recorded. Options yes, no. If yes, the type of antibiotic used will be recorded.
Measured: one week before surgery
Postoperative complications - fever
Fever is defined as a body temperature above 38 degrees Celsius
Measured: one week after surgery
Postoperative complications -circulatory instability
Presence of hypotension, MAP below 70 mm Hg
Measured: one week after surgery
Postoperative complications -I nfection
Presence of infection and origin of the infection in laboratory findings and in clinical picture.
Measured: one week after surgery
Postoperative complications - sepsis
Presence of sepsis and origin of the infection in laboratory findings and in clinical picture.
Measured: one week after surgery
Postoperative complications -postoperative delirum
Presence of postoperative delirium. To determine the diagnose CAM-ICU will be used.
Measured: one week after surgery
Postoperative complications - antibiotic
Administered antibiotic treatment and its duration
Measured: one week after surgery
Secondary outcomes (2)
Clinical frailty scale (CFS) preoperatively
The CFS is a nine-point scale based on clinical evaluation of mobility, energy, physical activity, and function.
Clinical Frailty Scale Components: 1. Very fit, 2. Well, 3. Managing Well:, 4. Living With Very Mild Frailty, 5. Living with Mild Frailty: 6. Living With Moderate Frailty, 6. Living With Severe Frailty, 8. Living with Very Severe Frailty, 9. Terminally Ill
Measured: one week before surgery
Preoperative antibiotic therapy
Preoperatively, it will be assessed whether the patient received antibiotic treatment for a urinary tract infection prior to surgery. The result will be recorded as yes or no.
Measured: one week before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Jun 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
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 InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomas Bata Hospital, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klára Nekvindová, Tomas Bata Hospital, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896643
- Sponsor's protocol ID
- 2024-32
- Status last verified
- Jul 2025
- First submitted
- 4 Mar 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parvizi J, Koo KH. Should a Urinary Tract Infection Be Treated before a Total Joint Arthroplasty? Hip Pelvis. 2019 Mar;31(1):1-3. doi: 10.5371/hp.2019.31.1.1. Epub 2019 Mar 5.
PubMed 30899708
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Infection and Colonization in Bone Procedures
- ClinicalTrials.gov ID
- NCT06896643
- Acronym / sponsor ID
- 2024-32
- Keywords
- urinary, tract, infection, colonization, postoperative complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tomas Bata Hospital, Czech RepublicUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- 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.
For seniors aged 65 and over (inclusive) undergoing surgical procedures (bone surgery, traumatology, orthopedics) in an acute or elective setting, the relationship between preoperative urinary tract infection/colonization (within 30 days before the procedure) and the occurrence of predefined postoperative complications (monitoring during the patients' hospitalization) will be observed
Detailed description
For seniors aged 65 and over (inclusive) undergoing surgical procedures (bone surgery, traumatology, orthopedics) in an acute or elective setting, the relationship between preoperative urinary tract infection/colonization (within 30 days before the procedure) and the occurrence of predefined postoperative complications (monitoring during the patients' hospitalization) will be observed Among the monitored parameters before the surgical procedure will be urine collection (chemical + sediment - a common part of the pre-anesthetic examination), and in case of findings, a sample for bacteriological examination will be indicated. Additionally, subjective symptoms (present, absent), presence of fever, whether the infection/finding in the urine was treated or not, and whether a control urine examination was performed (performed, not performed) will be recorded. The origin of the patient (home, social care facility) and the planned surgical procedure will be noted. The Clinical Frailty Scale, type of anesthesia (general, regional), and any administered antibiotic treatment will also be recorded.
After the surgical procedure, the occurrence of urinary infection (yes, no, sample not taken) will be assessed. Postoperative complications such as fever, circulatory instability, development of delirium, infection, septic state, and death will be monitored. The trajectory of the respondent during hospitalization (which departments they will be treated in, including the length of hospitalization) will be recorded. The primary goal will be to determine the relationship between the preoperative occurrence of urinary infection or colonization in patients within the last 30 days before the procedure and the occurrence of predefined postoperative complications. Secondary goals will include identifying the most common postoperative complications in patients with preoperative urinary colonization or proven urinary infection. Additionally, the relationship between the preoperative Clinical Frailty Scale in the defined patient population and the occurrence of predefined postoperative complications will be examined. The final secondary goal will be to determine preoperative antibiotic therapy in the preoperative period.
The cohort of traumatology patients undergoing surgical procedures was chosen to ensure the homogeneity of the studied population (seniors over 65 undergoing bone surgery).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- For seniors over 65 years (including), undergoing surgery (bone procedure, traumatology, orthopedics) in an acute or elective mode, the relationship between preoperative infection/colonization of the urinary tract (within 30 days before the procedure) and the occurrence of predefined postoperative complications will be monitored.
Key inclusion criteria (4 listed)
- Age over 65 years, including
- Elective or acute trauma/orthopedic bone surgery
- Urine examination as part of pre-anesthetic examination, urine + sediment, in case of suspicion - bacteriological examination
- Signed informed consent for research as part of pre-anesthetic examination (I or II), respecting informed consent as an expression of the patient's "free will"
Key exclusion criteria (10 listed)
- Negative finding in urine: chemical examination + sediment preoperatively
- Respondent under the influence of premedication, alcohol, or drugs
- Sensory impairment (blindness)
- Delirious preoperative state
- Severe mental disorder
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
Urinary tract infection preoperatively - signs and symptoms
Time frame: one week before surgery
Signs and symptoms include dysuria, frequency, urgency, or/and fever or/and smelling urine and non-specific signs (nausea, malaise)
Urinary tract infection preoperatively - urinary dipstick test.
Time frame: one week before surgery
Positive urine dipstict test (i.e. nitrate-reductace and leukocyte esterase detection).
Urinary tract infection preoperatively - chemical examination of the urine and sediment - pH
Time frame: one week before surgery
Positive result in chemical examination of the urine and the sediment for the possibility of infection s: pH ≥ 6.
Urinary tract infection preoperatively: chemical examination - proteinuria (urine dipstick test)
Time frame: one week before surgery
Detection of proteinuria with urine dipstick test.
Urinary tract infection preoperatively - leukocytouria (urine dipstick test)
Time frame: one week before surgery
Positive result t is leukocyturia (detection of leucocyte esteras) in a dipstick test.
Urinary tract infection preoperatively chemical examination of the urine and sediment -pyuria (urine dipstick test)
Time frame: one week before surgery
Pyuria, which is the presence of white blood cells in the urine, will detected through these methods: Postive urine dipstick test - showing leukocyte esterase or nitrites. And additionally have to present: discoloration, clouding or change in the smell of urine for a pyuria
Urinary tract infection preoperatively: chemical examination of the urine and sediment -bacteriuria (urine dipstick test)
Time frame: one week before surgery
Presence of bacteriuria (presence of bacteria in the urine). Can be detected through urine dipstick test (determination of presence of leukocyte esterase and nitrites, which are indicators of white blood cells and bacteria in the urine)
Urinary tract infection preoperatively - chemical examination preoperatively - chemical examination of the urine and sediment -bacteriuria
Time frame: one week before surgery
Presence of bacteriuria (presence of bacteria in the urine). Can be detected through through flow cytometry (this method detects bacteria in urinary samples in the range from 40 up to 1000/μl),
Urinary tract infection preoperatively: chemical examination of the urine and sediment -bacteriuria (urine culture)
Time frame: one week before surgery
Presence of bacteriuria (presence of bacteria in the urine). Can be detected through urine culture (bacteria grow from a urine sample, cutoff is for a significant bacterial count is typically greater than 100,000 colony-forming units (CFU) per mililiter).
Urinary tract infection preoperatively - chemical examination preoperatively - chemical examination of the urine and sediment - proteinuria
Time frame: one week before surgery
Detection of proteinuria with the sulfosalicylic acid test in laboratory. A semiquantitative scale is used for evaluation: 1. Opalescence - approximate concentration of protein in g/l: 0,05-0,1 2. Slight turbidity (transparent, underlying text can be read - approximate concentration of protein in g/l: 0,1-0,2 3. Milky turbidity (opaque, without flakes) - approximate concentration of protein in g/l: 0,5-1,0 4. Milky turbidity with flake formation: approximate concentration of protein in g/l: 2,0-5,0 5. Flocculent precipitate: approximate concentration of protein in g/l ≥ 5,0
Urinary tract infection preoperatively - leukocytouria (sediment)
Time frame: one week before surgery
Positive result is finding in the in sediment more than 10 leukocytes per field of view.
Urinary tract infection preoperatively chemical examination of the urine and sediment -pyuria (microscopy)
Time frame: one week before surgery
Pyuria, which is the presence of white blood cells in the urine, will detected through these methods: Microscopy - cell counts performer by microscopy, positive finding is more than 10 leukocytes per field of view. And additionally have to present: discoloration, clouding or change in the smell of urine for a pyuria.
Urinary tract colonization preoperatively - asymptomatic bacteriuria, women (urine culture)
Time frame: one week before surgery
Midstream clean catch urine specimen will be needed. Two consecutive specimens with isolation of the same bacteria species with at least 100,000 colony-forming units (CFUs) per ml of urine.
Urinary tract colonization preoperatively - asymptomatic bacteriuria, men (urine culture)
Time frame: one week before surgery
Midstream clean catch urine specimen will be needed. For men, a single specimen with isolation of one bacteria species with at least 100,000 CFUs per ml of urine.
Urinary tract colonization preoperatively - asymptomatic bacteriuria, catheterized specimen (urine culture))
Time frame: one week before surgery
For women or men, a single specimen with isolation of one bacteria species with at least 100 CFUs per ml of urine.
Antibiotic therapy before the surgery
Time frame: one week before surgery
Preoperative antibiotic use will be recorded. Options yes, no. If yes, the type of antibiotic used will be recorded.
Postoperative complications - fever
Time frame: one week after surgery
Fever is defined as a body temperature above 38 degrees Celsius
Postoperative complications -circulatory instability
Time frame: one week after surgery
Presence of hypotension, MAP below 70 mm Hg
Postoperative complications -I nfection
Time frame: one week after surgery
Presence of infection and origin of the infection in laboratory findings and in clinical picture.
Postoperative complications - sepsis
Time frame: one week after surgery
Presence of sepsis and origin of the infection in laboratory findings and in clinical picture.
Postoperative complications -postoperative delirum
Time frame: one week after surgery
Presence of postoperative delirium. To determine the diagnose CAM-ICU will be used.
Postoperative complications - antibiotic
Time frame: one week after surgery
Administered antibiotic treatment and its duration
2 secondary outcomes
Clinical frailty scale (CFS) preoperatively
Time frame: one week before surgery
Preoperative antibiotic therapy
Time frame: one week before surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Background: PubMed 30899708Parvizi J, Koo KH. Should a Urinary Tract Infection Be Treated before a Total Joint Arthroplasty? Hip Pelvis. 2019 Mar;31(1):1-3. doi: 10.5371/hp.2019.31.1.1. Epub 2019 Mar 5.
- 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.
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 Infection and Complications, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 8 Jul 2025. 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 Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Klára Nekvindová, M.D., Ph.D. (+420 577 551 111, nekvindova.klara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract infection preoperatively - signs and symptoms (time frame: one week before surgery). The study lists 22 primary outcomes in all. 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 NCT06896643, 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 8 Jul 2025.