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

NCT06946667 | Completed

• 1 other identifier: No. 2025-008
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection Complicated; Kidney Stones; Antimicrobial Resistance

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (2)

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

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

Interventions

the UTI group OTHER

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 UTI group

the Non-UTI group OTHER

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

Eligibility Criteria

• Age: 44 Years - 62 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xingxin Jiang: lead

Study Sites (1)

Suzhou Hospital of Integrated Traditional Chinese and Western Medicine

Suzhou, Jiangsu, 215101, China

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 27, 2025
• Study Start: February 9, 2021
• Primary Completion: December 10, 2024
• Study Completion: December 31, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-01

Locations

CN (1)