Clinical trial NCT02579161: Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy
Official title: Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Stones
Keywords: Percutaneous Nephrolithotomy
Kidney Stones
Antibiotics
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Infectious Complications
timeFrame: 0-30 days post-operatively
Secondary outcomes:
measure: Length of Stay (Days)
timeFrame: 0-30 days post operatively
measure: Number of Participants With Associated Clavien Grade of Adverse Event
timeFrame: 0 to 30 days after surgery
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
Study officials:
affiliation: Northwell Health
name: Zeph Okeke, MD
role: PRINCIPAL_INVESTIGATOR
References: