Preoperative Antibiotic PNL Study
Information source: University of British Columbia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Stones; Renal Calculi
Intervention: nitrofurantoin monohydrate/macrocrystalline (Drug); ampicillin (Drug); gentamicin or vancomycin /ceftriaxone (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s): Roger Sur, MD, Principal Investigator, Affiliation: San Diego University
Summary
Percutaneous nephrolithotomy (PCNL) is a surgical procedure that is standard of care for the
removal of large kidney stones. PCNL involves removal of the stone(s) from the kidney
through a temporary tract that is percutaneously placed through the patient's back during
surgery. There is a significant risk of urinary tract infection after PCNL but wide clinical
variation in use of prophylactic antibiotics in the days leading up to surgery. For patients
who had already agreed to undergo PCNL, we plan to randomize them either to 1 week of
preoperative antibiotic prophylaxis plus < 24 hours of perioperative IV antibiotics or to <
24 hours of perioperative IV antibiotics only. We will then compare the rates of infectious
complications following PCNL for the two groups.
Clinical Details
Official title: The EDGE Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy: Part 1
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: rate of postoperative sepsis
Secondary outcome: rate of nonseptic bacteruriastone-free rate Lenght of Stay (LOS)
Eligibility
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All subjects (Age ≥19 years) undergoing PCNL for any size stone can be potentially be
included.
Exclusion Criteria:
- eGFR < 60 mL/min/1. 73 m2
- Cirrhosis and/or hepatitis
- Pregnancy
- Positive preoperative urine culture within 3 months
- 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 3 months prior to randomization
- Severe hydronephrosis (defined by ≥ 2cm in largest dimension) preoperatively as
judged on CT scan, abdominal X-ray, ultrasound, or fluoroscopy.
Locations and Contacts
Mayo Clinic - Scottsdale/Phoenix, AZ, Scottsdale, Arizona 85259, United States
The Stone Centre, VGH/UBC, Vancouver, British Columbia V5Z 1M9, Canada
Johns Hopkins University, Baltimore, Maryland 21287, United States
Harvard University - Massachusetts General Hospital, Boston, Massachusetts 02114-3117, United States
Mayo Clinic - Rochester, MN, Rochester, Minnesota 55905, United States
Dartmouth University, Lebanon, New Hampshire 03756-0001, United States
New York University, New York, New York 10016, United States
Duke University, Durham, North Carolina 27710, United States
Ohio State University, Athens, Ohio 45701, United States
Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
Vanderbilt University, Nashville, Tennessee 37235, United States
Additional Information
Starting date: March 2015
Last updated: April 2, 2015
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