The EDGE Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy: Part 1
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 8
- 主要终点
- Number of Participants That Developed Sepsis After Surgery
研究概览
简要总结
When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care.
This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).
详细描述
- Study Design or Overview This study will be a multi-institutional randomized, controlled clinical trial of a course of a 1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily leading up to PCNL. The control group will be no preoperative oral antibiotics. The participating institutions are academic medical centers in the United States and Canada that are part of the EDGE (Endourologic Disease Group of Excellence) research consortium, a research collaborative that has the goal of producing high quality, multi-institutional studies of nephrolithiasis. Separate IRB approvals will be obtained at each institution. UCSD will be the coordinating institution. Member institutions of EDGE maintain frequent email contact with one another and hold a monthly teleconference to discuss safety updates, interim results, issues with accrual, and modifications to research protocols and consents (if necessary).
Treatment Assignment:
Patients will be assigned to control or intervention arm based on a predetermined allocation sequence that will be generated by a computerized random number generator. Patients will be stratified by institution in permuted blocks of varying size. No clinical staff involved in recruiting and consenting patients for the study at UCSD or other participating institutions will have knowledge of the allocation sequence at their institution prior to enrollment of each patient. To further aid allocation concealment, the block size will be varied.
Standard of care procedures:
Patients will be identified based on clinic visits or hospital admission. All patients will be counseled on standard treatment options- extracorporeal shock wave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL) and ureteroscopy (URS). The discussion regarding treatment options and subsequent care will not deviate from routine care. Patients consenting for PCNL will be considered for enrollment into the study and will be enrolled to have data collected prospectively. Patients will be consented prior to prescription of antibiotics and to the surgery for collection of demographic, disease, perioperative, and postoperative data. Abdominal pelvic computed tomography (CT), if not already obtained, will be used to delineate pre-operative stone size and for preoperative planning. If the patient does not consent to the study the use of antibiotics will be based on the routine clinical practice of the treating urologist. Both prophylaxis with preoperative antibiotics and no prophylaxis (i.e. periprocedural only) are considered standard of care and this study will examine the difference between these two common practices.
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
- •Renal stone of any size for which PCNL is recommended
排除标准
- •eGFR < 60 mL/min/1.73 m2
- •cirrhosis and/or hepatitis
- •Pregnancy
- •Positive preoperative urine culture within 2 weeks
- •History of temperature >=38.3 C associated with nephrolithiasis or sepsis thought to be due to urinary source within 12 months prior to randomization
- •Current internalized ureteral stent, nephrostomy tube, or nephroureteral stent
- •Antibiotic use within 2 weeks prior to randomization
- •Severe hydronephrosis (defined by > =2cm in largest dimension) preoperatively as judged on CT scan, abdominal X-ray, ultrasound, or fluoroscopy.
研究组 & 干预措施
Antibiotic
1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily starting 1 week prior to planned kidney stone surgery (PCNL).
In addition, each patient receives a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.
干预措施: nitrofurantoin monohydrate/macrocrystalline capsules (Drug)
Antibiotic
1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily starting 1 week prior to planned kidney stone surgery (PCNL).
In addition, each patient receives a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.
干预措施: ampicillin (Drug)
Antibiotic
1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily starting 1 week prior to planned kidney stone surgery (PCNL).
In addition, each patient receives a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.
干预措施: gentamicin (Drug)
Antibiotic
1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily starting 1 week prior to planned kidney stone surgery (PCNL).
In addition, each patient receives a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.
干预措施: vancomycin (Drug)
Antibiotic
1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily starting 1 week prior to planned kidney stone surgery (PCNL).
In addition, each patient receives a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.
干预措施: ceftriaxone (Drug)
No preoperative oral antibiotics
Each patient does receive a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.
干预措施: ampicillin (Drug)
No preoperative oral antibiotics
Each patient does receive a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.
干预措施: gentamicin (Drug)
No preoperative oral antibiotics
Each patient does receive a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.
干预措施: vancomycin (Drug)
No preoperative oral antibiotics
Each patient does receive a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.
干预措施: ceftriaxone (Drug)
结局指标
主要结局
Number of Participants That Developed Sepsis After Surgery
时间窗: Within 7 days following day of surgery
"Sepsis" will be defined by the 2012 International Guidelines for Management of Severe Sepsis and Septic Shock where 2 or more of the following variables are present and temporally associated * Temp \> 38.3 C or \<36 C * 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 * WBC \>12000 or \< 4000
次要结局
- Positive Bladder Urine Culture(once, within 30 minutes of start of surgery)
- Number of Participants With a Postoperative Fever Greater Than 38.3 Celsius(within 7 days following day of surgery)
- Participants With Positive Renal Pelvic Urine Culture(once at time of surgery, within 10 minutes of obtaining percutaneous access to the kidney)
- Participants With Positive Kidney Stone Culture(once, within 6 hours of start of surgery)
- Number and Grade of Postoperative Complications Following Surgery as Graded by the Clavien-Dindo Complication Scale(Within 12 weeks following day of surgery)
- Hospital Length of Stay After Surgery(Within 12 weeks following day of surgery)
- Number of Partcipants That Were Stone Free After Surgery(Within 12 weeks following day of surgery)
- Number of Participants With Postoperative Urinary Tract Infection (UTI)(Within 12 weeks following day of surgery)
- Number of Participants Admitted to Intensive Care Unit (ICU) After Surgery(within 7 days following day of surgery)
研究者
Roger L Sur, M.D.
Fellow
University of California, San Diego