Overview

A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])

Status:
Completed
Trial end date:
2019-06-01
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of California, San Diego
Collaborators:
Dartmouth-Hitchcock Medical Center
Duke University
Mayo Clinic
New York University
Ohio State University
The Cleveland Clinic
University of British Columbia
Vanderbilt University
Treatments:
Ampicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Ceftriaxone
Gentamicins
Nitrofurantoin
Vancomycin
Criteria
Inclusion Criteria:

- Renal stone of any size for which PCNL is recommended

Exclusion Criteria:

- 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.