Tomas Bata Hospital
Zlín, 76001, Czechia
Location status: Recruiting
Location contact
Klára Nekvindová, M.D., Ph.D.
CONTACT
Tomáš Gabrhelík, doc., M.D., Ph.D.
CONTACT
NCT Number: NCT06896643
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
Interested in participating?
Request Info65 year and older
All sexes
Observational
Zlín, 76001, Czechia
Location status: Recruiting
Klára Nekvindová, M.D., Ph.D.
CONTACT
Tomáš Gabrhelík, doc., M.D., Ph.D.
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: one week before surgery
Positive urine dipstict test (i.e. nitrate-reductace and leukocyte esterase detection).
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.
Time frame: one week before surgery
Detection of proteinuria with urine dipstick test.
Time frame: one week before surgery
Positive result t is leukocyturia (detection of leucocyte esteras) in a 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
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)
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),
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).
Time frame: one week before surgery
Detection of proteinuria with the sulfosalicylic acid test in laboratory.
A semiquantitative scale is used for evaluation:
Time frame: one week before surgery
Positive result is finding in the in sediment more than 10 leukocytes per field of view.
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.
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.
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.
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.
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.
Time frame: one week after surgery
Fever is defined as a body temperature above 38 degrees Celsius
Time frame: one week after surgery
Presence of hypotension, MAP below 70 mm Hg
Time frame: one week after surgery
Presence of infection and origin of the infection in laboratory findings and in clinical picture.
Time frame: one week after surgery
Presence of sepsis and origin of the infection in laboratory findings and in clinical picture.
Time frame: one week after surgery
Presence of postoperative delirium. To determine the diagnose CAM-ICU will be used.
Time frame: one week after surgery
Administered antibiotic treatment and its duration
Time frame: one week before surgery
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
Time frame: one week before surgery
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.
Contact information is provided by the study sponsor or research team.
Tomas Bata Hospital, Czech Republic
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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