Urinary Infection and Colonization in Bone Procedures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorTomas Bata Hospital, Czech Republic
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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"
Disqualifiers
Negative finding in urine: chemical examination + sediment preoperatively
Respondent under the influence of premedication, alcohol, or drugs
Sensory impairment (blindness)
Delirious preoperative state
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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)
Time frame
one week before surgery2
Urinary tract infection preoperatively - urinary dipstick test.
Positive urine dipstict test (i.e. nitrate-reductace and leukocyte esterase detection).
Time frame
one week before surgery3
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.
Time frame
one week before surgery4
Urinary tract infection preoperatively: chemical examination - proteinuria (urine dipstick test)
Detection of proteinuria with urine dipstick test.
Time frame
one week before surgerySecondary outcomes
1
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
Time frame
one week before surgery2
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.
Time frame
one week before surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov