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临床试验/NCT06210425
NCT06210425已完成不适用

Is Re-examination of Urine Culture Necessary for Patients With Preoperative Positive Results in Predicting Infectious Complications Related to Mini-Percutaneous Nephrolithotomy?

Junhao Zheng1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
147
试验地点
1
主要终点
SIRS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

SIRS

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Junhao Zheng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Junhao Zheng

Resident

The First Affiliated Hospital of Guangzhou Medical University

研究点 (1)

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