Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Number of Participants With Infectious Complications
研究概览
简要总结
The Investigators objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.
详细描述
For large renal stone burdens and/or complex stones, Percutaneous Nephrolithotomy (PCNL) has become the mainstay for treatment, replacing open kidney stone surgery since it's introduction in 1976. However, PCNL is not without its complications, specifically infectious. The procedure carries up to 25% incidence of infectious complications with approximately 1% rate of severe sepsis even with completely sterile conditions. Therefore, the use of antibiotics becomes paramount, but to date there are no PNCL specific guidelines for the appropriate duration and class of antibiotics. This fact leaves the practicing urologists to their own subjective experiences to the guide them. In addition, in an age where there are increasing numbers of resistant microbes the judicious use of antibiotics is in even more paramount.
The investigators of this project, purpose a randomized intention to treat prospective study to explore the duration and type of antibiotics in a larger population then previously studied. The investigators hypothesize that there will be no difference in complications between two groups: 1) 24 hours of perioperative antibiotics versus 2) Continued antibiotics until the removal of any external catheters. The investigators will model the antibiotics choices and duration after the 2013 American Urological Association, (AUA) Urologic Surgery Antimicrobial Prophylaxis recommendations, modified by our local antibiogram as necessary. The investigators' objective is to compare the clinical efficacy of a single-day protocol with a short-course protocol for PCNL. Our hope is to reduce the use of possibly unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further propagation of resistant microbes.
Antibiotic detail: cephalosporins or aminoglycoside + metronidazole or clindamycin and the alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone
Looking at the same drugs and doses the variable is the timeframe of the medication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients >18 years old
- •Negative urine culture within 1 month prior to procedure
- •Renal Calculi which would optimally require PCNL for treatment.
排除标准
- •Patients <18 years old.
- •Patients who are not able to give consent for study
- •Patients currently on antibiotics immediately prior to the procedure
- •Previous history of sepsis or SIRS from stone manipulations
- •Foley catheter in place for greater than 1 week duration
- •Patients under going planned, multi-staged procedures
- •Immunosuppressed patients
研究组 & 干预措施
Antibiotics for a 24 hour period
Antibiotics for a 24 hour period
Intervention drug to be determined based on patient history etc.
干预措施: cephalosporins (Drug)
Antibiotics for a 24 hour period
Antibiotics for a 24 hour period
Intervention drug to be determined based on patient history etc.
干预措施: Fluoroquinolones (Drug)
Antibiotics for a 24 hour period
Antibiotics for a 24 hour period
Intervention drug to be determined based on patient history etc.
干预措施: Clindamycin (Drug)
Antibiotics for a 24 hour period
Antibiotics for a 24 hour period
Intervention drug to be determined based on patient history etc.
干预措施: Ampicillin/Gentamicin (Drug)
Continued antibiotics
Continued antibiotics until the removal of any external catheters
Intervention drug to be determined based on patient history etc.
干预措施: cephalosporins (Drug)
Continued antibiotics
Continued antibiotics until the removal of any external catheters
Intervention drug to be determined based on patient history etc.
干预措施: Fluoroquinolones (Drug)
Continued antibiotics
Continued antibiotics until the removal of any external catheters
Intervention drug to be determined based on patient history etc.
干预措施: Clindamycin (Drug)
Continued antibiotics
Continued antibiotics until the removal of any external catheters
Intervention drug to be determined based on patient history etc.
干预措施: Ampicillin/Gentamicin (Drug)
结局指标
主要结局
Number of Participants With Infectious Complications
时间窗: 0-30 days post-operatively
Compare the rate of infectious complications following a single-dose of peri-operative protocol (antibiotics for 24 hours as recommended by the American Urological Association Guidelines) with a short-course protocol (antibiotics continued until any external catheters such as nephrostomy tubes are removed) following percutaneous nephrolithotomy. Complication rate differences, primarily infectious complications such as fever, sepsis, systemic inflammatory response.
次要结局
- Length of Stay (Days)(0-30 days post operatively)
- Number of Participants With Associated Clavien Grade of Adverse Event(0 to 30 days after surgery)