The Endourology Disease Group for Excellence (EDGE) Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy in Patients With Moderate Risk of Postoperative Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- postoperative sepsis
研究概览
简要总结
This study will be a multi-institutional randomized clinical trial of a short course of pre-operative antibiotic prophylaxis in addition to perioperative antibiotics prior to undergoing percutaneous nephrolithotomy. The select patient population will be those patients deemed to be at a moderately increased risk of postoperative infectious complications. These higher risk patients are those with indwelling urinary drainage tubes and those with a positive preoperative urine culture.
详细描述
This study will be a multi-institutional randomized clinical trial of a short course of pre-operative antibiotic prophylaxis in addition to perioperative antibiotics. Once patients have been identified and enrolled into the study, they will be grouped based on the sensitivity profiles of their positive urine culture or the presence of indwelling kidney drain tube (nephrostomy tube, nephroureteral stent, ureteral stent). Each of these groups will be individually randomized as follows:
Group 1) Kidney stone subjects with indwelling drain tube (nephrostomy tube or ureteral stent) and negative urine culture
Randomization:
- 7 day course of oral Macrobid (Nitrofurantoin) 100 mg twice daily + <24 hours perioperative intravenous (IV) antibiotics
- 48 hours perioperative oral Macrobid (Nitrofurantoin) 100mg twice daily + <24 hours perioperative IV antibiotics
Group 2) Kidney stone subjects with positive urine culture sensitive to oral antibiotics
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1a: Indwelling drains (48 hr)
This group has indwelling urinary tubes/drains and a negative urine culture
- Nitrofurantoin (Macrobid) 100 mg oral bid for 48 hours prior to surgery
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Gentamicin, 5mg/kg (Drug)
1a: Indwelling drains (48 hr)
This group has indwelling urinary tubes/drains and a negative urine culture
- Nitrofurantoin (Macrobid) 100 mg oral bid for 48 hours prior to surgery
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Ampicillin 2g (Drug)
1a: Indwelling drains (48 hr)
This group has indwelling urinary tubes/drains and a negative urine culture
- Nitrofurantoin (Macrobid) 100 mg oral bid for 48 hours prior to surgery
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Nitrofurantoin 100 mg, 48 hrs (Drug)
1b: Indwelling drains (7d)
This group has indwelling urinary tubes/drains and a negative urine culture
- Nitrofurantoin (Macrobid) 100 mg oral bid for 7 days prior to surgery
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Nitrofurantoin 100 MG, 7d (Drug)
1b: Indwelling drains (7d)
This group has indwelling urinary tubes/drains and a negative urine culture
- Nitrofurantoin (Macrobid) 100 mg oral bid for 7 days prior to surgery
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Gentamicin, 5mg/kg (Drug)
1b: Indwelling drains (7d)
This group has indwelling urinary tubes/drains and a negative urine culture
- Nitrofurantoin (Macrobid) 100 mg oral bid for 7 days prior to surgery
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Ampicillin 2g (Drug)
2a: +UCx with Oral Options (48hr)
This group has a positive pre-operative urine culture with oral antibiotic options
- Nitrofurantoin (Macrobid) 100 mg oral bid for 48 hours prior to surgery
- If patient has previous allergies to Macrobid and/or sensitivity profile indicates Macrobid resistance, then one antibiotic will be provided in the following order: nitrofurantoin > sulfamethoxazole-trimethoprim > doxycycline> ciprofloxacin > cephalexin > cefpodoxime.
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Gentamicin, 5mg/kg (Drug)
2a: +UCx with Oral Options (48hr)
This group has a positive pre-operative urine culture with oral antibiotic options
- Nitrofurantoin (Macrobid) 100 mg oral bid for 48 hours prior to surgery
- If patient has previous allergies to Macrobid and/or sensitivity profile indicates Macrobid resistance, then one antibiotic will be provided in the following order: nitrofurantoin > sulfamethoxazole-trimethoprim > doxycycline> ciprofloxacin > cephalexin > cefpodoxime.
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Ampicillin 2g (Drug)
2a: +UCx with Oral Options (48hr)
This group has a positive pre-operative urine culture with oral antibiotic options
- Nitrofurantoin (Macrobid) 100 mg oral bid for 48 hours prior to surgery
- If patient has previous allergies to Macrobid and/or sensitivity profile indicates Macrobid resistance, then one antibiotic will be provided in the following order: nitrofurantoin > sulfamethoxazole-trimethoprim > doxycycline> ciprofloxacin > cephalexin > cefpodoxime.
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Nitrofurantoin 100 mg, 48 hrs (Drug)
2b: +UCx with Oral Options (7d)
This group has a positive pre-operative urine culture with oral antibiotic options
- Nitrofurantoin (Macrobid) 100 mg oral bid for 7 days prior to surgery
- If patient has previous allergies to Macrobid and/or sensitivity profile indicates Macrobid resistance, then one antibiotic will be provided in the following order: nitrofurantoin > sulfamethoxazole-trimethoprim > doxycycline> ciprofloxacin > cephalexin > cefpodoxime.
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Nitrofurantoin 100 MG, 7d (Drug)
2b: +UCx with Oral Options (7d)
This group has a positive pre-operative urine culture with oral antibiotic options
- Nitrofurantoin (Macrobid) 100 mg oral bid for 7 days prior to surgery
- If patient has previous allergies to Macrobid and/or sensitivity profile indicates Macrobid resistance, then one antibiotic will be provided in the following order: nitrofurantoin > sulfamethoxazole-trimethoprim > doxycycline> ciprofloxacin > cephalexin > cefpodoxime.
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Gentamicin, 5mg/kg (Drug)
2b: +UCx with Oral Options (7d)
This group has a positive pre-operative urine culture with oral antibiotic options
- Nitrofurantoin (Macrobid) 100 mg oral bid for 7 days prior to surgery
- If patient has previous allergies to Macrobid and/or sensitivity profile indicates Macrobid resistance, then one antibiotic will be provided in the following order: nitrofurantoin > sulfamethoxazole-trimethoprim > doxycycline> ciprofloxacin > cephalexin > cefpodoxime.
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Ampicillin 2g (Drug)
3a: +UCx No Oral options (48hr)
This group has a positive pre-operative urine culture with no oral antibiotic options based on culture sensitivities
- 48 hour course of an IV/Intramuscular (IM) antibiotic (proven effective on sensitivity profile)
- Gentamicin (80 mg) preferred if sensitive
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Gentamicin, 5mg/kg (Drug)
3a: +UCx No Oral options (48hr)
This group has a positive pre-operative urine culture with no oral antibiotic options based on culture sensitivities
- 48 hour course of an IV/Intramuscular (IM) antibiotic (proven effective on sensitivity profile)
- Gentamicin (80 mg) preferred if sensitive
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Ampicillin 2g (Drug)
3a: +UCx No Oral options (48hr)
This group has a positive pre-operative urine culture with no oral antibiotic options based on culture sensitivities
- 48 hour course of an IV/Intramuscular (IM) antibiotic (proven effective on sensitivity profile)
- Gentamicin (80 mg) preferred if sensitive
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Gentamicin, 80 mg, 48hr (Drug)
3b: +UCx No Oral options (7d)
This group has a positive pre-operative urine culture with no oral antibiotic options based on culture sensitivities
- 7 day course of an IV/Intramuscular (IM) antibiotic (proven effective on sensitivity profile)
- Gentamicin (80 mg) preferred if sensitive
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Gentamicin, 5mg/kg (Drug)
3b: +UCx No Oral options (7d)
This group has a positive pre-operative urine culture with no oral antibiotic options based on culture sensitivities
- 7 day course of an IV/Intramuscular (IM) antibiotic (proven effective on sensitivity profile)
- Gentamicin (80 mg) preferred if sensitive
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Ampicillin 2g (Drug)
3b: +UCx No Oral options (7d)
This group has a positive pre-operative urine culture with no oral antibiotic options based on culture sensitivities
- 7 day course of an IV/Intramuscular (IM) antibiotic (proven effective on sensitivity profile)
- Gentamicin (80 mg) preferred if sensitive
- All patient receive ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 120 minutes of surgery start time.
干预措施: Gentamicin, 80 mg, 7d (Drug)
结局指标
主要结局
postoperative sepsis
时间窗: 30 days
Sepsis will be defined by the 2012 International Guidelines for the Management of Severe Sepsis and Septic Shock where 2 or more of the following variables are present and temporally associated * Temp \> 38.3C or \<36C * Heart Rate \> 90/min (at least 12 hrs after surgery) * Respiratory Rate \>20/min (at least 12 hrs after surgery) * Altered mental status: defined as lack of orientation to either name, place or time/date * Systolic Blood Pressure (SBP) \<90 mmHg, Mean Arterial Pressure \<70 mmHg, or SBP decrease \>40 mmHg in adults * White blood cell (WBC) \> 12000 or \<4000
次要结局
- stone-free rate(30 days)
- Length of hospital stay(30 days)
- rate of nonseptic bacteruria(30 days)
研究者
Roger L Sur, M.D.
Professor of Surgery
University of California, San Diego