Do Dynamic Urinary Leukocyte and Nitrite Changes Improve Risk Prediction for Infectious Complications Following PCNL?

NCT07238673 | Completed

• 1 other identifier: GYFYZJH1015
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

Brief Summary

Background Percutaneous nephrolithotomy (PCNL) is widely recognized as the primary surgical approach for managing sizable and anatomically complex kidney stones., yet postoperative infection-related complications remain common and potentially severe. Preoperative urine culture plays an important role in perioperative antibiotic guidance but is limited by delayed reporting and suboptimal sensitivity. Urinalysis is simple, cost-effective, and repeatable; however, most existing studies focus on single static measurements and lack systematic evaluation of temporal trends. Objective To evaluate the association between temporal changes in preoperative urinary white blood cells (WBC) and nitrite (NIT) and the risk of postoperative fever and urosepsis in patients undergoing PCNL.

Conditions

Kidney Calculi; Urinary Tract Infections; Sepsis

Keywords

urolithiasis; percutaneous nephrolithotomy; urinalysis; postoperative infection

Outcome Measures

Primary Outcomes (2)

• Postoperative Fever

  Postoperative Fever was identified when body temperature reached or exceeded 38.0 °C.

  Within 7 days postoperatively

• Urosepsis

  Urosepsis was diagnosed according to the Sepsis-3 criteria: confirmed urinary tract infection and a Sequential Organ Failure Assessment (SOFA) score ≥ 2.

  Within 7 days postoperatively

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study was based on a prospectively maintained observational cohort of patients undergoing PCNL at the Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, between March 2021 and July 2025

You may qualify if:

• Age ≥ 18 years
• Renal stone diameter ≥ 2 cm, or complex renal stones, or failure of extracorporeal shock-wave lithotripsy (ESWL)
• American Society of Anesthesiologists (ASA) physical status class I or II
• Positive outpatient midstream urine culture

You may not qualify if:

• Age \< 18 years
• Fever on admission
• Concomitant renal tumor; Active, symptomatic urinary tract infection
• Use of antibiotics for other reasons within 1 month prior to admission
• Preoperative indwelling ureteral stent, nephrostomy tube, or double-J stent
• Uncontrolled diabetes mellitus
• Chronic kidney disease stage IIIa or higher (eGFR \< 60 mL/min/1.73 m²)
• Ongoing immunosuppressive therapy; Simultaneous bilateral renal stone surgery
• Severe comorbidities (e.g., respiratory or circulatory failure) that preclude anesthesia or surgery
• Pregnancy or lactation

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, GuangGong, 510500, China

Location

MeSH Terms

Conditions

Kidney Calculi; Urinary Tract Infections; Sepsis; Urolithiasis

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: March 1, 2021
• Primary Completion: July 1, 2025
• Study Completion: July 30, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)