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临床试验/NCT04374188
NCT04374188Unknown不适用

Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy: A Randomized Controlled Trial

Diaa Eldin Taha Ramadan Mohamed1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月1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
发起方
入组人数
200
试验地点
1
主要终点
Effect of ciprofloxacin versus levofloxacin duration before PCNL

研究概览

简要总结

Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial.

详细描述

To figure out the value of oral ciprofloxacin medication in ameliorate the outcome of renal nephrolithiasis extraction via the endoscope as regard the sepsis.

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
Double (Care Provider, Outcomes Assessor)

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

  • Patient 18 years or older
  • Stones ≥ 2 cm and/or mild to moderate hydronephrosis
  • Sterile mid urine stream

排除标准

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

研究组 & 干预措施

ciprofloxacin

Active Comparator

ciprofloxacin tablets

干预措施: Ciprofloxacin (Drug)

levofloxacin

Active Comparator

levofloxacin tablets

干预措施: Levofloxacin (Drug)

结局指标

主要结局

Effect of ciprofloxacin versus levofloxacin duration before PCNL

时间窗: 12 months

To evaluate whether 7 days of ciprofloxacin or levofloxacin before PCNL, can reduce upper urinary tract infection and urosepsis after PCNL.

次要结局

  • predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL.(12 months)
  • differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine(12 months)

研究者

发起方
Diaa Eldin Taha Ramadan Mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Diaa Eldin Taha Ramadan Mohamed

Lecturer of urology

Kafrelsheikh University

研究点 (1)

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