Is it Necessary for Patients With a Positive Urine Culture to Achieve a Negative Result After Antimicrobial Treatment Before Undergoing Percutaneous Nephrolithotomy?

NCT06210425 | Completed

• 1 other identifier: 12440100455344205E
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Kidney Calculi; Urinary Tract Infections; Sepsis

Keywords

Percutaneous nephrolithotomy; Urine culture; Antibiotics; Infectious complication; Sepsis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Within 7 days postoperatively

Study Arms (2)

Preoperative urine culture positive group

Preoperative urine culture was positive

Preoperative urine culture negative group

preoperative urine culture was negative

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Junhao Zheng: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, GuangGong, 510500, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine culture

MeSH Terms

Conditions

Kidney Calculi; Urinary Tract Infections; Sepsis

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; 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: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 18, 2024
• Study Start: March 1, 2021
• Primary Completion: October 30, 2024
• Study Completion: November 10, 2024
• Last Updated: November 21, 2025

Record last verified: 2024-01

Locations

CN (1)