Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy



Status:Recruiting
Conditions:Nephrology, Nephrology
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:8/24/2018
Start Date:September 2014
End Date:July 2019

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The Investigators objective is to compare the clinical efficacy of a single-day protocol with
a short-course protocol for PCNL. The investigator hope is to reduce the use of possibly
unnecessary prolonged antibiotic use, reduce hospital costs and prevent the further
propagation of resistant microbes.

For large renal stone burdens and/or complex stones, Percutaneous Nephrolithotomy (PCNL) has
become the mainstay for treatment, replacing open kidney stone surgery since it's
introduction in 1976. However, PCNL is not without its complications, specifically
infectious. The procedure carries up to 25% incidence of infectious complications with
approximately 1% rate of severe sepsis even with completely sterile conditions. Therefore,
the use of antibiotics becomes paramount, but to date there are no PNCL specific guidelines
for the appropriate duration and class of antibiotics. This fact leaves the practicing
urologists to their own subjective experiences to the guide them. In addition, in an age
where there are increasing numbers of resistant microbes the judicious use of antibiotics is
in even more paramount.

The investigators of this project, purpose a randomized intention to treat prospective study
to explore the duration and type of antibiotics in a larger population then previously
studied. The investigators hypothesize that there will be no difference in complications
between two groups: 1) 24 hours of perioperative antibiotics versus 2) Continued antibiotics
until the removal of any external catheters. The investigators will model the antibiotics
choices and duration after the 2013 American Urological Association, (AUA) Urologic Surgery
Antimicrobial Prophylaxis recommendations, modified by our local antibiogram as necessary.
The investigators' objective is to compare the clinical efficacy of a single-day protocol
with a short-course protocol for PCNL. Our hope is to reduce the use of possibly unnecessary
prolonged antibiotic use, reduce hospital costs and prevent the further propagation of
resistant microbes.

Antibiotic detail: cephalosporins or aminoglycoside + metronidazole or clindamycin and the
alternative for allergies being aminoglycoside/ sulbactam or fluoroquinolone

Looking at the same drugs and doses the variable is the timeframe of the medication

Inclusion Criteria:

- Patients >18 years old

- Negative urine culture within 1 month prior to procedure

- Renal Calculi which would optimally require PCNL for treatment.

Exclusion Criteria:

- Patients <18 years old.

- Patients who are not able to give consent for study

- Patients currently on antibiotics immediately prior to the procedure

- Previous history of sepsis or SIRS from stone manipulations

- Foley catheter in place for greater than 1 week duration

- Patients under going planned, multi-staged procedures

- Immunosuppressed patients
We found this trial at
2
sites
270-05 76th Ave
New Hyde Park, New York 11040
(718) 470-7480
Principal Investigator: Zeph Okeke, MD
Phone: 516-734-8500
Long Island Jewish Medical Center Serving North Shore LIJ Health System employees and their families....
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New Hyde Park, NY
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
Principal Investigator: Zeph Okeke, MD
Phone: 516-734-8500
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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mi
from
Manhasset, NY
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