DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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 bacteruria

stone-free rate

Lenght of Stay (LOS)


Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017