A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02384200|
Recruitment Status : Completed
First Posted : March 10, 2015
Results First Posted : August 22, 2019
Last Update Posted : August 22, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Nephrolithiasis Urinary Tract Infections||Drug: nitrofurantoin monohydrate/macrocrystalline capsules Drug: ampicillin Drug: gentamicin Drug: vancomycin Drug: ceftriaxone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The EDGE Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy: Part 1|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||February 1, 2017|
|Actual Study Completion Date :||June 1, 2019|
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.
Drug: nitrofurantoin monohydrate/macrocrystalline capsules
1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily
Other Name: Macrobid
IV (2 g)
IV (5 mg/kg)
IV (1 g)
IV (2 g)
Active Comparator: 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.
IV (2 g)
IV (5 mg/kg)
IV (1 g)
IV (2 g)
- Number of Participants That Developed Sepsis After Surgery [ Time Frame: 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
- Participants With Positive Renal Pelvic Urine Culture [ Time Frame: once at time of surgery, within 10 minutes of obtaining percutaneous access to the kidney ]percutaneously taken renal pelvic urine culture
- Participants With Positive Kidney Stone Culture [ Time Frame: once, within 6 hours of start of surgery ]Kidney stone sent for culture
- Positive Bladder Urine Culture [ Time Frame: once, within 30 minutes of start of surgery ]bladder urine culture taken during kidney stone surgery
- Number of Participants With Postoperative Urinary Tract Infection (UTI) [ Time Frame: Within 12 weeks following day of surgery ]symptomatic urinary tract infection
- Number of Participants With a Postoperative Fever Greater Than 38.3 Celsius [ Time Frame: within 7 days following day of surgery ]Body temperature >= 38.3 degrees Celsius
- Number of Participants Admitted to Intensive Care Unit (ICU) After Surgery [ Time Frame: within 7 days following day of surgery ]admission to ICU level nursing unit during primary hospitalization following kidney stone surgery (PCNL).
- Number and Grade of Postoperative Complications Following Surgery as Graded by the Clavien-Dindo Complication Scale [ Time Frame: Within 12 weeks following day of surgery ]The Clavien-Dindo grading scale, originally described in 2004, is a widely used throughout surgery to grade adverse events (i.e. complications) which occur as a result of surgical procedures; it is used in most urology units and has become the standard classification system for many surgical specialities. The grading system uses a Grade I - Grade V scale, with Grade V being the most severe.
- Hospital Length of Stay After Surgery [ Time Frame: Within 12 weeks following day of surgery ]Number of days in a hospital setting after kidney stone surgery (defined as number of midnights in hospitalization)
- Number of Partcipants That Were Stone Free After Surgery [ Time Frame: Within 12 weeks following day of surgery ]the absence of stone fragments >2mm on postoperative imaging following kidney stone surgery (PCNL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384200
|United States, Arizona|
|Mayo Clinic in Arizona|
|Phoenix, Arizona, United States, 85054|
|United States, California|
|UCSD Medical Center|
|San Diego, California, United States, 92103|
|San Francisco, California, United States|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|The Ohio State University Wexner Medical Center|
|Columbus, Ohio, United States, 43212|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232-2765|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||Roger L Sur, MD||University of California, San Diego|
|Study Director:||Daniel L Miller, MD MPH||University of California, San Diego|