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临床试验/NCT03178292
NCT03178292Unknown不适用

Conventional Antibiotic Prophylaxis Versus Add-On 5 Days Levofloxacin Before Percutaneous Nephrolithotomy (PCNL)

Mansoura University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Upper urinary tract infection and systemic inflammatory response syndrome (SIRS) after PCNL by Criteria for SIRS established by the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference

研究概览

简要总结

To evaluate whether 5 days of levofloxacin before percutaneous nephrolithotomy (PCNL) in reducing upper urinary tract infection and urosepsis after PCNL.

详细描述

Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure for removal of large volume upper urinary tract stones. Although PCNL is effective and yielding high stone-free rates, complications rates range from 18.30% to 83% with sepsis has been reported in 0.3% to 7.6% of cases result in the most common cause of perioperative mortality in PCNL patients.

Urosepsis after PNL is an important and potentially catastrophic complication. The overall incidence of fever (25%), bacteremia (23%), endotoxemia (34%) and septicemic shock occurs in 0.3%-2.5% of patients. Urosepsis and shock result from the intravasation of bacteria or endotoxins into bloodstream, which in turn increases with prolonged surgery, degree of hydronephrosis, bacterial load in the renal pelvis, and presence of infected stones.

Charton et al., concluded that without antibiotic prophylaxis 35% of patient suffered urinary tract infection a post-PCNL, although preoperative urine showing no growth. In a prospective but nonrandomized assessment of PCNL patients receiving oral ciprofloxacin, intravenous ciprofloxacin, or no antimicrobial treatment found postoperative urinary tract infection to occur in 17%, 0%, and 40% of patients, respectively. Mariappan et al., stated that midstream urine (MSU) culture does not represent upper tract infection in patients with obstructing stones. Also, stone and pelvic urine cultures are better predictors of upper tract infection and urosepsis in such cases.

Antibiotic prophylaxis has been recommended (Level of evidence: IIb, III) for patients subjected to PCNL to avert these infectious complications, as profiled in an American Urological Association (AUA) Best Practice Policy Statement. They also recommend antibiotic prophylaxis before shock wave lithotripsy and ureteroscopy with high level (Level of evidence: Ia and Ib, respectively) due to presence of meta-analysis and large randomised controlled trial.

The optimal timing, dosing, and duration of a prophylactic antibiotic regimen for PCNL procedures has also been a point of discussion. The AUA best practice policy statement currently recommends that a one-time dose on the day of the procedure is sufficient. The EAU guidelines are less definitive in concluding that a short course is adequate but that the "length of time is to be determined." Mariappan and colleagues in a prospective non-randomised trial found that 52 patients who had dilated collecting systems, stone burden greater than 2 cm, and no confounding factors predisposing to UTIs who received a 1-week course of ciprofloxacin before PCNL had a 3-fold lower risk of postoperative UTI and SIRS than 46 patients who received standard perioperative antibiotics on the day of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Stones ≥ 2.5 cm and/or hydronephrosis
  • Sterile mid urine stream

排除标准

  • Patients with a stent, nephrostomy tube or indwelling catheter
  • Uncontrolled Diabetes mellitus
  • Renal failure
  • Fever before surgery
  • Concomitant bladder stone or tumour
  • Patients with active UTI
  • Contralateral renal/ureteric stone

研究组 & 干预措施

Levofloxacin

Active Comparator

Levofloxacin 500 mg daily for 5 days

干预措施: Levofloxacin (Drug)

Placebo

Placebo Comparator

Placebo tab daily for 5 days

干预措施: Placebo (Drug)

结局指标

主要结局

Upper urinary tract infection and systemic inflammatory response syndrome (SIRS) after PCNL by Criteria for SIRS established by the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference

时间窗: 1 year

SIRS if patient has Two or more of the 4 SIRS criteria

次要结局

  • difference between culture and sensitivity of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone.(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelwahab Hashem

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Mansoura University

研究点 (1)

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