Urinary Infection and Colonization in Bone Procedures

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

Study Overview

• Status: Recruiting
• Conditions: Frailty; Urinary Tract Infection; Complications; Urinary Tract Infection (Diagnosis)

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Klára Nekvindová, M.D., Ph.D.; Phone Number: +420 577 551 111; Email: nekvindova.klara@gmail.com

Study Locations

• Czechia
  • Zlín, Czechia, 76001
    • Recruiting
    • Tomas Bata Hospital
    • Contact: Klára Nekvindová, M.D., Ph.D.; Phone Number: +420 577 551 111; Email: nekvindova.klara@gmail.com
    • Contact: Tomáš Gabrhelík, doc., M.D., Ph.D.; Phone Number: + 420 577 552 280; Email: Tomas.Gabrhelik@bnzlin.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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"

Exclusion Criteria:

• 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
• coma
• Septic state
• Acute respiratory failure
• Disagreement with participation in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	one week before surgery
Urinary tract infection preoperatively - urinary dipstick test.	Positive urine dipstict test (i.e. nitrate-reductace and leukocyte esterase detection).	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.	one week before surgery
Urinary tract infection preoperatively: chemical examination - proteinuria (urine dipstick test)	Detection of proteinuria with urine dipstick test.	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.	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	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)	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),	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).	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	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.	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.	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.	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.	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.	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.	one week before surgery
Postoperative complications - fever	Fever is defined as a body temperature above 38 degrees Celsius	one week after surgery
Postoperative complications -circulatory instability	Presence of hypotension, MAP below 70 mm Hg	one week after surgery
Postoperative complications -I nfection	Presence of infection and origin of the infection in laboratory findings and in clinical picture.	one week after surgery
Postoperative complications - sepsis	Presence of sepsis and origin of the infection in laboratory findings and in clinical picture.	one week after surgery
Postoperative complications -postoperative delirum	Presence of postoperative delirium. To determine the diagnose CAM-ICU will be used.	one week after surgery
Postoperative complications - antibiotic	Administered antibiotic treatment and its duration	one week after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	one week before surgery

Collaborators and Investigators

• Sponsor: Tomas Bata Hospital, Czech Republic

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 6, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: infection; colonization; postoperative complications; urinary; tract
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Frailty; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: 2024-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No