Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 412
- 试验地点
- 1
- 主要终点
- Symptomatic urinary tract infection
研究概览
简要总结
The purpose of the study is to investigate whether the use of gentamicin-based irrigation fluid during ureteroscopy decreases the risk of UTIs and other post-operative infections after surgery.
详细描述
The primary objective of this study is to determine whether the utilization of gentamicin-based irrigation fluid during ureteroscopy decreases the rate of 30-day post-operative symptomatic urinary tract infections in patients at higher risk of urinary tract infection undergoing stone surgery for urolithiasis.
The secondary objectives of this study are to determine whether the utilization of gentamicin-based irrigation fluid during ureteroscopy affects the 30-day post-operative rates of patient-initiated telephone calls, readmission rates, urosepsis rates based on SIRS criteria, and overall post-operative oral/intravenous antibiotic administration.
In this prospective study, 120 mg of gentamicin prepared in 3 liters of normal saline will be used as irrigation during ureteroscopic surgery for urolithiasis. At this concentration, 40 μg/mL, the MBC would be achieved for pathogenic urogenital bacteria. Due to the concerns of nephrotoxicity and ototoxicity at higher doses of gentamicin, in the unlikely event of complete pyelo-venous backflow, the intravenous circulation of 120 mg of gentamicin would be less than the surgical prophylaxis intravenous dosing for patients weighing more than 60 kg. For the single intravenous dose for surgical prophylaxis, post-operative monitoring of renal function, and gentamicin peak and trough levels are not routinely obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Diagnosed with urolithiasis (obstructing ureteral stone, large non-obstructing renal stones) warranting surgical intervention in line with American Urological Association guidelines for urolithiasis
- •At a higher risk for infectious complications following ureteroscopy based on a history of atleast one of the below:
- •3 more urinary tract infections over 12 month period not on suppressive antibiotic therapy
- •Prior infectious complication following ureteroscopy
- •Placement of ureteral stent in the setting of obstructing ureteral stone with concern for superimposed urinary tract infection
- •Positive pre-operative urine culture treated with culture-appropriate antimicrobial therapy
- •Planned for cystoscopy, ureteroscopy with possible laser lithotripsy, and ureteral stent placement
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 8 weeks after the end of gentamicin administration. Female patients of reproductive potential will have pregnancy screen prior to surgery per standard operating room protocol.
- •For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
排除标准
- •Estimated Glomerular Filtration Rate less than 60 mL/min
- •History of sensorineural hearing loss, vertigo, idiopathic dizziness
- •Active pregnancy or currently lactating
- •Known allergic reactions to components of gentamicin
- •Administration of intravenous gentamicin as part of surgical antibiotic prophylaxis
研究组 & 干预措施
Gentamicin-Based Irrigation
This group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy
干预措施: Gentamicin (Drug)
3 L NaCl Irrigation
This group will receive the typical NaCl irrigation used during ureteroscopy
干预措施: Placebo (Other)
结局指标
主要结局
Symptomatic urinary tract infection
时间窗: Within 30 days of surgery
Development of a symptomatic urinary tract infection after surgery
次要结局
- Patient self-reported symptoms(within 30 days of surgery)
- Urosepsis(Within 30 days of surgery)
- Re-admission to hospital(Within 30 days of surgery)