Urinary Infection and Colonization in Bone Procedures

Обзор

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

Подробное описание

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).

Первичные конечные точки

• Urinary tract infection preoperatively - signs and symptoms [Срок оценки: one week before surgery]
• Urinary tract infection preoperatively - urinary dipstick test. [Срок оценки: one week before surgery]
• Urinary tract infection preoperatively - chemical examination of the urine and sediment - pH [Срок оценки: one week before surgery]
• Urinary tract infection preoperatively: chemical examination - proteinuria (urine dipstick test) [Срок оценки: one week before surgery]
• Urinary tract infection preoperatively - leukocytouria (urine dipstick test) [Срок оценки: one week before surgery]
• Urinary tract infection preoperatively chemical examination of the urine and sediment -pyuria (urine dipstick test) [Срок оценки: one week before surgery]
• Urinary tract infection preoperatively: chemical examination of the urine and sediment -bacteriuria (urine dipstick test) [Срок оценки: one week before surgery]
• Urinary tract infection preoperatively - chemical examination preoperatively - chemical examination of the urine and sediment -bacteriuria [Срок оценки: one week before surgery]
• Urinary tract infection preoperatively: chemical examination of the urine and sediment -bacteriuria (urine culture) [Срок оценки: one week before surgery]
• Urinary tract infection preoperatively - chemical examination preoperatively - chemical examination of the urine and sediment - proteinuria [Срок оценки: one week before surgery]

Вторичные конечные точки (2)

• Clinical frailty scale (CFS) preoperatively [Срок оценки: one week before surgery]
• Preoperative antibiotic therapy [Срок оценки: one week before surgery]

Критерии участия

Критерии включения

• 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"

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Чехия · 1 центр

• Tomas Bata Hospital — Zlín

Публикации

• 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. PMID 30899708

Идентификаторы

NCT: NCT06896643 · 2024-32

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗