Kidney CalculiNCT07238673
Do Dynamic Urinary Leukocyte and Nitrite Changes Improve Risk Prediction for Infectious Complications Following PCNL?
An observational study of Kidney Calculi and Urinary Tract Infections, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Calculi, Urinary Tract Infections, Sepsis
- How many people
- 346 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Jul 2025
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, GuangGong, 510500
About this study
Official title: Dynamic Changes in Preoperative Urinary Leukocytes and Nitrite as Predictors of Infectious Complications After Percutaneous Nephrolithotomy
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.
Read the detailed description
Introduction
Urolithiasis represents one of the most frequently encountered disorders in urological practice, and its global incidence has been increasing steadily in recent years, making it a significant public health concern that not only impairs patients' quality of life while creating considerable financial strain and increasing demands on healthcare systems . Percutaneous nephrolithotomy (PCNL) is now the primary therapeutic option recommended by international guidelines for medium-to-large and complex renal calculi, owing to its proven efficacy, minimal invasiveness, and rapid recovery . However, unavoidable factors during this procedure-such as high-pressure irrigation, migration of stone fragments, and injury to the renal pelvic mucosa-may facilitate the translocation of bacteria and endotoxins into the bloodstream, thereby triggering postoperative infectious complications, particularly fever and urosepsis. These complications can significantly impair postoperative recovery and prognosis and may even pose life-threatening risks .
Currently, preoperative urine culture is routinely used to assess a patient's infectious status and to guide perioperative antibiotic administration. However, this method has certain limitations, including a prolonged turnaround time (48-72 hours), susceptibility to sampling contamination, and the intermittent nature of bacteriuria, which restrict its utility in rapid clinical decision-making. In contrast, urinalysis is an economical, convenient, and repeatable test that is widely applied in preoperative evaluation. Among its parameters, urinary white blood cells (WBC) detected by microscopy and urinary nitrite (NIT) can serve as indirect indicators of urinary tract infection. Previous studies have demonstrated that preoperative WBC or NIT positivity is significantly associated with postoperative infectious complications following PCNL. A meta-analysis involving 6,113 patients reported that preoperative WBC positivity (OR ≈ 3.86) and NIT positivity (OR ≈ 7.81) were both independent risk factors. However, most of these studies were based on a single measurement and lacked a systematic evaluation of preoperative dynamic trends.
On this basis, the present study proposes a new clinical question: Can the dynamic changes in preoperative urinalysis WBC and NIT serve as effective predictors of postoperative infection risk in patients undergoing PCNL? To address this, we prospectively collected urinalysis data at admission and immediately before surgery, stratified patients according to dynamic change patterns, and analyzed the associations with postoperative fever and urosepsis, with the aim of providing a reference for clinical risk stratification and individualized anti-infective strategies.
- Conditions
- Kidney Calculi, Urinary Tract Infections, Sepsis
- Keywords
- urolithiasis, percutaneous nephrolithotomy, urinalysis, postoperative infection
- Medical subject headings
- Kidney Calculi, Urinary Tract Infections, Sepsis, Urolithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Fever
Postoperative Fever was identified when body temperature reached or exceeded 38.0 °C.
Measured: 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.
Measured: Within 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Mar 2021
- Primary completion1 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junhao Zheng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238673
- Sponsor's protocol ID
- GYFYZJH1015
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes in Preoperative Urinary Leukocytes and Nitrite as Predictors of Infectious Complications After Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT07238673
- Acronym / sponsor ID
- GYFYZJH1015
- Conditions
- Kidney Calculi, Urinary Tract Infections, Sepsis
- Keywords
- urolithiasis, percutaneous nephrolithotomy, urinalysis, postoperative infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction
Urolithiasis represents one of the most frequently encountered disorders in urological practice, and its global incidence has been increasing steadily in recent years, making it a significant public health concern that not only impairs patients' quality of life while creating considerable financial strain and increasing demands on healthcare systems . Percutaneous nephrolithotomy (PCNL) is now the primary therapeutic option recommended by international guidelines for medium-to-large and complex renal calculi, owing to its proven efficacy, minimal invasiveness, and rapid recovery . However, unavoidable factors during this procedure-such as high-pressure irrigation, migration of stone fragments, and injury to the renal pelvic mucosa-may facilitate the translocation of bacteria and endotoxins into the bloodstream, thereby triggering postoperative infectious complications, particularly fever and urosepsis. These complications can significantly impair postoperative recovery and prognosis and may even pose life-threatening risks .
Currently, preoperative urine culture is routinely used to assess a patient's infectious status and to guide perioperative antibiotic administration. However, this method has certain limitations, including a prolonged turnaround time (48-72 hours), susceptibility to sampling contamination, and the intermittent nature of bacteriuria, which restrict its utility in rapid clinical decision-making. In contrast, urinalysis is an economical, convenient, and repeatable test that is widely applied in preoperative evaluation. Among its parameters, urinary white blood cells (WBC) detected by microscopy and urinary nitrite (NIT) can serve as indirect indicators of urinary tract infection. Previous studies have demonstrated that preoperative WBC or NIT positivity is significantly associated with postoperative infectious complications following PCNL. A meta-analysis involving 6,113 patients reported that preoperative WBC positivity (OR ≈ 3.86) and NIT positivity (OR ≈ 7.81) were both independent risk factors. However, most of these studies were based on a single measurement and lacked a systematic evaluation of preoperative dynamic trends.
On this basis, the present study proposes a new clinical question: Can the dynamic changes in preoperative urinalysis WBC and NIT serve as effective predictors of postoperative infection risk in patients undergoing PCNL? To address this, we prospectively collected urinalysis data at admission and immediately before surgery, stratified patients according to dynamic change patterns, and analyzed the associations with postoperative fever and urosepsis, with the aim of providing a reference for clinical risk stratification and individualized anti-infective strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Fever
Time frame: Within 7 days postoperatively
Postoperative Fever was identified when body temperature reached or exceeded 38.0 °C.
Urosepsis
Time frame: Within 7 days postoperatively
Urosepsis was diagnosed according to the Sepsis-3 criteria: confirmed urinary tract infection and a Sequential Organ Failure Assessment (SOFA) score ≥ 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Calculi and Urinary Tract Infections, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Fever (time frame: Within 7 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.