Clinical trial NCT06946667: Resistance Characteristics and Development of Diagnostic Model for Postoperative UTI in Patients With Kidney Stones
Official title: Pathogen Resistance Characteristics and Development of a Combined Diagnostic Model Using Hs-CRP, HBP, NGAL, and ADPN for Postoperative Urinary Tract Infections in Patients With Kidney Stones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection Complicated
Kidney Stones
Antimicrobial Resistance
Lead sponsor: Suzhou Hospital of Integrated Traditional Chinese and Western Medicine
Sponsor class: OTHER_GOV
First posted: 2025-04-27
Enrollment: 130
Sex: ALL
Minimum age (years): 44
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 130 patients diagnosed with kidney stones and treated at our hospital between February 2021 and December 2024 were enrolled in this study. Based on the presence of postoperative UTI, patients were categorized into the UTI group (n=41) and the Non-UTI group (n=89). The mean age of patients in the UTI group was 52.76±8.49 years, comprising 24 males and 17 females, whereas the Non-UTI group had a mean age of 53.03±7.12 years, including 43 males and 46 females.

Brief summary: The combined detection of HBP, ADPN, NGAL, and hs-CRP enables the construction of a highly efficient diagnostic model, offering a novel strategy for early infection identification and risk stratification after surgery.

Detailed description: This study investigated pathogen distribution, antimicrobial resistance, and the diagnostic utility of biomarkers (hs-CRP, HBP, NGAL, ADPN) for Urinary Tract Infections (UTI) after kidney stone surgery. A total of 130 patients with kidney stones, treated between February 2021 and December 2024, were included in this study. Based on the occurrence of postoperative UTIs, they were categorized into the UTI group (n=41) and the Non-UTI group (n=89). Laboratory parameters, including WBC, NLR, NEU, hs-CRP, HBP, NGAL, and ADPN levels, were measured. Midstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing. Pearson correlation analysis was performed to assess the relationships among these biomarkers, ROC curve analysis was conducted to evaluate diagnostic performance, and logistic regression analysis was used to identify independent risk factors for postoperative infections.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years;
2. Diagnosis of urinary calculi confirmed by CT, X-ray, or ultrasound;
3. Complete clinical data available. -

Exclusion Criteria:

1. Presence of active UTI or other infections prior to surgery;
2. Coexisting urological disorders (e.g., bladder cancer, neurogenic bladder);
3. Prolonged use of immunosuppressants or antibiotics (\>2 weeks). -

Primary outcomes:
measure: Pathogen Resistance Characteristics and Development of a Combined Diagnostic Model Using hs-CRP, HBP, NGAL, and ADPN for Postoperative Urinary Tract Infections in Patients with Kidney Stones
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Suzhou Hospital of Integrated Traditional Chinese and Western Medicine
state: Jiangsu
Study officials:
References: