Clinical trial NCT06896643: Urinary Infection and Colonization in Bone Procedures
Official title: Urinary Infection and Colonization in Bone Procedures
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Urinary Tract Infection
Complications
Urinary Tract Infection (Diagnosis)
Frailty
Keywords: urinary
tract
infection
colonization
postoperative complications
Lead sponsor: Tomas Bata Hospital, Czech Republic
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 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).

Eligibility criteria: 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

Primary outcomes:
measure: Urinary tract infection preoperatively - signs and symptoms
timeFrame: one week before surgery
measure: Urinary tract infection preoperatively - urinary dipstick test.
timeFrame: one week before surgery
measure: Urinary tract infection preoperatively - chemical examination of the urine and sediment - pH
timeFrame: one week before surgery
measure: Urinary tract infection preoperatively: chemical examination - proteinuria (urine dipstick test)
timeFrame: one week before surgery
measure: Urinary tract infection preoperatively - leukocytouria (urine dipstick test)
timeFrame: one week before surgery
measure: Urinary tract infection preoperatively chemical examination of the urine and sediment -pyuria (urine dipstick test)
timeFrame: one week before surgery
measure: Urinary tract infection preoperatively: chemical examination of the urine and sediment -bacteriuria (urine dipstick test)
timeFrame: one week before surgery
measure: Urinary tract infection preoperatively - chemical examination preoperatively - chemical examination of the urine and sediment -bacteriuria
timeFrame: one week before surgery
measure: Urinary tract infection preoperatively: chemical examination of the urine and sediment -bacteriuria (urine culture)
timeFrame: one week before surgery
measure: Urinary tract infection preoperatively - chemical examination preoperatively - chemical examination of the urine and sediment - proteinuria
timeFrame: one week before surgery
measure: Urinary tract infection preoperatively - leukocytouria (sediment)
timeFrame: one week before surgery
measure: Urinary tract infection preoperatively chemical examination of the urine and sediment -pyuria (microscopy)
timeFrame: one week before surgery
measure: Urinary tract colonization preoperatively - asymptomatic bacteriuria, women (urine culture)
timeFrame: one week before surgery
measure: Urinary tract colonization preoperatively - asymptomatic bacteriuria, men (urine culture)
timeFrame: one week before surgery
measure: Urinary tract colonization preoperatively - asymptomatic bacteriuria, catheterized specimen (urine culture))
timeFrame: one week before surgery
measure: Antibiotic therapy before the surgery
timeFrame: one week before surgery
measure: Postoperative complications - fever
timeFrame: one week after surgery
measure: Postoperative complications -circulatory instability
timeFrame: one week after surgery
measure: Postoperative complications -I nfection
timeFrame: one week after surgery
measure: Postoperative complications - sepsis
timeFrame: one week after surgery
measure: Postoperative complications -postoperative delirum
timeFrame: one week after surgery
measure: Postoperative complications - antibiotic
timeFrame: one week after surgery
Secondary outcomes:
measure: Clinical frailty scale (CFS) preoperatively
timeFrame: one week before surgery
measure: Preoperative antibiotic therapy
timeFrame: one week before surgery
Other outcomes:
Locations:
city: Zlín
country: Czechia
facility: Tomas Bata Hospital
Study officials:
References:
citation: 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.