Kidney CalculiNCT06210425
Is it Necessary for Patients With a Positive Urine Culture to Achieve a Negative Result After Antimicrobial Treatment Before Undergoing Percutaneous Nephrolithotomy?
An observational study of Kidney Calculi and Urinary Tract Infections, run by Junhao Zheng at 1 site in China.
Trial summary
Objective: The current European Association of Urology (EAU) guidelines do not provide clear recommendations on whether patients with a positive urine culture(UC) should wait until the culture turns negative following antimicrobial treatment before undergoing percutaneous nephrolithotomy (PCNL). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Calculi, Urinary Tract Infections, Sepsis
- How many people
- 147 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 10 Nov 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients received treatment with sensitive antibiotics for 5 to 7 days based on the drug susceptibility results of their initial UC upon admission. Follow-up UCs were performed on the third day after starting antibiotic treatment and again immediately before the surgery. An analysis was conducted to examine the relationship between UC results at the two specified time points and the occurrence of infectious complications following PCNL.
Who may be able to join
- Age ≥ 18 years.
- Renal stone diameter ≥ 2 cm, complex renal stones, or failed ESWL treatment.
- Consent to undergo PCNL with a positive midstream urine culture preoperatively.
- ASA score of I or II.
Who cannot join
- Coexisting renal tumor.
- Use of antibiotics within the past two weeks.
- Renal dysfunction (serum creatinine \>451 μmol/L).
- Unresolved hemorrhage or coagulation abnormalities.
- Patients who have undergone percutaneous renal fistula or have a ureteral stent in place on the affected side.
- Simultaneous bilateral renal stone surgery.
- Severe underlying diseases, such as respiratory or circulatory insufficiency, that cannot tolerate anesthesia or surgery.
- Pregnant or lactating women.
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: Is Re-examination of Urine Culture Necessary for Patients With Preoperative Positive Results in Predicting Infectious Complications Related to Mini-Percutaneous Nephrolithotomy?
Objective: The current European Association of Urology (EAU) guidelines do not provide clear recommendations on whether patients with a positive urine culture(UC) should wait until the culture turns negative following antimicrobial treatment before undergoing percutaneous nephrolithotomy (PCNL). This study evaluates the necessity of achieving a negative UC after treatment with sensitive antibiotics before performing PCNL.
Methods: A prospective, continuous study was carried out involving patients with a positive UC who underwent percutaneous nephrolithotomy (PCNL) at the Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, between March 2021 and April 2024. Patients received treatment with sensitive antibiotics for 5 to 7 days based on the drug susceptibility results of their initial UC upon admission. Follow-up UCs were performed on the third day after starting antibiotic treatment and again immediately before the surgery. An analysis was conducted to examine the relationship between UC results at the two specified time points and the occurrence of infectious complications following PCNL.
Read the detailed description
For large renal stones, percutaneous nephrolithotomy (PCNL) is the recommended standard surgical approach, especially in cases involving infectious renal stones. Postoperative infections have become the most common complication associated with PCNL, often necessitating additional antimicrobial treatment and prolonged hospitalization. Therefore, it is critically important to identify the risk factors linked to infections after PCNL. Preoperative UC directs antibiotic treatment and mitigates infectious complications post-PCNL. Even with negative preoperative UCs and suitable antibiotic treatment, SIRS or sepsis may still develop post-PCNL. Several studies have indicated that a preoperative UC obtained before antibiotic administration is not a reliable predictor of postoperative infectious complications. Nonetheless, there has been limited research on the relationship between repeat UCs after antibiotic treatment and post-PCNL infectious complications. This research assesses the necessity of achieving a negative UC after treatment with sensitive antibiotics before undergoing PCNL.
- Conditions
- Kidney Calculi, Urinary Tract Infections, Sepsis
- Keywords
- Percutaneous nephrolithotomy, Urine culture, Antibiotics, Infectious complication, Sepsis
- Medical subject headings
- Kidney Calculi, Urinary Tract Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative urine culture positive group | Preoperative urine culture was positive | |
| Preoperative urine culture negative group | preoperative urine culture was negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
SIRS
The presence of at least two of the following four criteria defines SIRS following PCNL: heart rate greater than 90/min, white blood cell count ≥12 × 10^9/L or ≤4 × 10^9/L, body temperature above 38°C or under 36°C, and respiratory rate greater than 20/min.
Measured: Within 7 days postoperatively
Urosepsis
①Confirmed urinary tract infection; ②SOFA (Sequential Organ Failure Assessment) score ≥2 points. A diagnosis of urosepsis can be made if both of the above conditions are met.
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 posted18 Jan 2024
- Study start1 Mar 2021
- Primary completion30 Oct 2024
- Study completion10 Nov 2024
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Junhao Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Junhao Zheng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210425
- Sponsor's protocol ID
- 12440100455344205E
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Re-examination of Urine Culture Necessary for Patients With Preoperative Positive Results in Predicting Infectious Complications Related to Mini-Percutaneous Nephrolithotomy?
- ClinicalTrials.gov ID
- NCT06210425
- Acronym / sponsor ID
- 12440100455344205E
- Conditions
- Kidney Calculi, Urinary Tract Infections, Sepsis
- Keywords
- Percutaneous nephrolithotomy, Urine culture, Antibiotics, Infectious complication, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Junhao ZhengUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 18 Jan 2024 (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.
Objective: The current European Association of Urology (EAU) guidelines do not provide clear recommendations on whether patients with a positive urine culture(UC) should wait until the culture turns negative following antimicrobial treatment before undergoing percutaneous nephrolithotomy (PCNL). This study evaluates the necessity of achieving a negative UC after treatment with sensitive antibiotics before performing PCNL.
Methods: A prospective, continuous study was carried out involving patients with a positive UC who underwent percutaneous nephrolithotomy (PCNL) at the Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, between March 2021 and April 2024. Patients received treatment with sensitive antibiotics for 5 to 7 days based on the drug susceptibility results of their initial UC upon admission. Follow-up UCs were performed on the third day after starting antibiotic treatment and again immediately before the surgery. An analysis was conducted to examine the relationship between UC results at the two specified time points and the occurrence of infectious complications following PCNL.
Detailed description
For large renal stones, percutaneous nephrolithotomy (PCNL) is the recommended standard surgical approach, especially in cases involving infectious renal stones. Postoperative infections have become the most common complication associated with PCNL, often necessitating additional antimicrobial treatment and prolonged hospitalization. Therefore, it is critically important to identify the risk factors linked to infections after PCNL. Preoperative UC directs antibiotic treatment and mitigates infectious complications post-PCNL. Even with negative preoperative UCs and suitable antibiotic treatment, SIRS or sepsis may still develop post-PCNL. Several studies have indicated that a preoperative UC obtained before antibiotic administration is not a reliable predictor of postoperative infectious complications. Nonetheless, there has been limited research on the relationship between repeat UCs after antibiotic treatment and post-PCNL infectious complications. This research assesses the necessity of achieving a negative UC after treatment with sensitive antibiotics before undergoing PCNL.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative urine culture positive group | – | –Preoperative urine culture was positive |
| Preoperative urine culture negative group | – | –preoperative urine culture was negative |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients received treatment with sensitive antibiotics for 5 to 7 days based on the drug susceptibility results of their initial UC upon admission. Follow-up UCs were performed on the third day after starting antibiotic treatment and again immediately before the surgery. An analysis was conducted to examine the relationship between UC results at the two specified time points and the occurrence of infectious complications following PCNL.
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Renal stone diameter ≥ 2 cm, complex renal stones, or failed ESWL treatment.
- Consent to undergo PCNL with a positive midstream urine culture preoperatively.
- ASA score of I or II.
Key exclusion criteria (8 listed)
- Coexisting renal tumor.
- Use of antibiotics within the past two weeks.
- Renal dysfunction (serum creatinine \>451 μmol/L).
- Unresolved hemorrhage or coagulation abnormalities.
- Patients who have undergone percutaneous renal fistula or have a ureteral stent in place on the affected side.
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
SIRS
Time frame: Within 7 days postoperatively
The presence of at least two of the following four criteria defines SIRS following PCNL: heart rate greater than 90/min, white blood cell count ≥12 × 10^9/L or ≤4 × 10^9/L, body temperature above 38°C or under 36°C, and respiratory rate greater than 20/min.
Urosepsis
Time frame: Within 7 days postoperatively
①Confirmed urinary tract infection; ②SOFA (Sequential Organ Failure Assessment) score ≥2 points. A diagnosis of urosepsis can be made if both of the above conditions are met.
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 21 Nov 2025.
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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 Junhao Zheng 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 8 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 21 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?
SIRS (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 21 Nov 2025.