Do Dynamic Urinary Leukocyte and Nitrite Changes Improve Risk Prediction for Infectious Complicat… (NCT07238673) | Clinical Trial Compass
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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Fever
Timeframe: Within 7 days postoperatively
2
Urosepsis
Timeframe: Within 7 days postoperatively
Trial details
NCT IDNCT07238673
SponsorThe First Affiliated Hospital of Guangzhou Medical University