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

Completed · Phase 4

Conditions studied: Nephrolithiasis, Urinary Tract Infections

In brief

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).

Key facts

Study ID

NCT02384200

Run by

University of California, San Diego

People needed

86

Starts

2015-03-01

Expected to finish

2019-06-01

Last updated by the study team

2019-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Renal stone of any size for which PCNL is recommended

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic in Arizona — Phoenix, Arizona, United States
• UCSD Medical Center — San Diego, California, United States
• UCSF — San Francisco, California, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Vanderbilt — Nashville, Tennessee, United States
• University of British Columbia — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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