Resistance Characteristics and Development of Diagnostic Model for Postoperative UTI in Patients With Kidney Stones

April 20, 2025 updated by: Xingxin Jiang

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215101
        • Suzhou Hospital of Integrated Traditional Chinese and Western Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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.

Description

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). -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
the UTI group
Midstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing.
Other: the UTI group
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.
the Non-UTI group
Midstream clean-catch urine samples from patients in the UTI group were collected for pathogen identification and antimicrobial susceptibility testing.
Other: the Non-UTI group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 10 weeks
Postoperative UTI in kidney stone patients are primarily caused by Gram-negative bacteria with high resistance. Combined detection of hs-CRP, HBP, NGAL, and ADPN significantly improves diagnostic accuracy. HBP, NGAL, and ADPN serve as early predictive markers for postoperative infection, providing a reference for clinical practice.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xingxin Jiang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2021

Primary Completion (Actual)

December 10, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

April 6, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. 2025-008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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