Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy
- Conditions
- Kidney Stones
- Interventions
- Registration Number
- NCT02579161
- Lead Sponsor
- Northwell Health
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- Patients >18 years old
- Negative urine culture within 1 month prior to procedure
- Renal Calculi which would optimally require PCNL for treatment.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continued antibiotics cephalosporins Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. Continued antibiotics Fluoroquinolones Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. Antibiotics for a 24 hour period cephalosporins Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. Antibiotics for a 24 hour period Fluoroquinolones Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. Continued antibiotics Ampicillin/Gentamicin Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc. Antibiotics for a 24 hour period Ampicillin/Gentamicin Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. Antibiotics for a 24 hour period Clindamycin Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc. Continued antibiotics Clindamycin Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc.
- Primary Outcome Measures
Name Time Method Number of Participants With Infectious Complications 0-30 days post-operatively Compare the rate of infectious complications following a single-dose of peri-operative protocol (antibiotics for 24 hours as recommended by the American Urological Association Guidelines) with a short-course protocol (antibiotics continued until any external catheters such as nephrostomy tubes are removed) following percutaneous nephrolithotomy. Complication rate differences, primarily infectious complications such as fever, sepsis, systemic inflammatory response.
- Secondary Outcome Measures
Name Time Method Length of Stay (Days) 0-30 days post operatively Length of Hospital Stay After Surgery (days)
Number of Participants With Associated Clavien Grade of Adverse Event 0 to 30 days after surgery Overall complication rates are reported based on Clavien-Dindo scale. The numbers reported are recorded Clavien complications. There is only one Clavien complication per patient as such a recorded number indicates one complication of this classification and also one patient with this complication. For example, if a Clavien III is recorded, it is indicating that one patient in that study group had one Clavien III complication.
Grade I are any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention.
Grade II complications require drug treatments other than those allowed for Grade I complications; Grade III complications require surgical, endoscopic or radiological intervention either IIIa, not under general anesthesia or IIIb, under general anesthesia. Grade IV are Life-threatening complications. Grade V are most severe and result in death of the patient.
Trial Locations
- Locations (2)
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States