CompletedNot Applicable

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

China346 participantsStarted 2021-03-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Postoperative Fever

Timeframe: Within 7 days postoperatively

Urosepsis

Timeframe: Within 7 days postoperatively

Trial details

NCT IDNCT07238673

SponsorThe First Affiliated Hospital of Guangzhou Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-01