Urinary Infection and Colonization in Bone Procedures

NCT06896643 | Recruiting

• 1 other identifier: 2024-32
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Tract Infection; Complications; Urinary Tract Infection (Diagnosis); Frailty

Keywords

urinary; tract; infection; colonization; postoperative complications

Outcome Measures

Primary Outcomes (22)

• 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: 1. Opalescence - approximate concentration of protein in g/l: 0,05-0,1 2. Slight turbidity (transparent, underlying text can be read - approximate concentration of protein in g/l: 0,1-0,2 3. Milky turbidity (opaque, without flakes) - approximate concentration of protein in g/l: 0,5-1,0 4. Milky turbidity with flake formation: approximate concentration of protein in g/l: 2,0-5,0 5. 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 Outcomes (2)

• Clinical frailty scale (CFS) preoperatively

  one week before surgery

• Preoperative antibiotic therapy

  one week before surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomas Bata Hospital, Czech Republic: lead

Study Sites (1)

Tomas Bata Hospital

Zlín, 76001, Czechia

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections; Disease; Frailty; Infections; Postoperative Complications

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Klára Nekvindová, M.D., Ph.D.

CONTACT

+420 577 551 111; nekvindova.klara@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief for Science, Education, and Research

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 26, 2025
• Study Start: June 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)