Preoperative Antibiotic PNL Study

Status:	Enrolling by invitation
Conditions:	Renal Impairment / Chronic Kidney Disease, Nephrology, Nephrology
Therapuetic Areas:	Nephrology / Urology
Healthy:	No
Age Range:	19 - Any
Updated:	4/6/2016
Start Date:	March 2015
End Date:	December 2017

The EDGE Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy: Part 1

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.

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.

We found this trial at

sites

Duke University

Durham, North Carolina 27710

(919) 684-8111