Trial of Randomized Antibiotic Administration in Percutaneous Nephrolithotomy

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.

Study Overview

• Status: Completed
• Conditions: Kidney Stones
• Intervention / Treatment: Drug: cephalosporins; Drug: Fluoroquinolones; Drug: Clindamycin; Drug: Ampicillin/Gentamicin

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

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New Hyde Park, New York, United States, 11040
      • Long Island Jewish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Antibiotics for a 24 hour period; Antibiotics for a 24 hour period Intervention drug to be determined based on patient history etc.	Drug: cephalosporins; Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference. Ancef, a 1st generation cephalosporin, was used as the primary antibiotic, which was started within 60 minutes of the procedure. Dosing was 1 gram IV every 8 hours and was adjusted for renal dosing as needed; Other Names: ancef; Drug: Fluoroquinolones; If the patient has an allergy to penicillin or cephalosporin, then Ciprofloxacin was used instead and started within 120 minutes of the procedure at 400mg IV and would be continued every 12hrs if patient has a normal creatinine clearance; Other Names: ciprofloxacin; Drug: Clindamycin; If allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision.; Other Names: Lincosamides; Drug: Ampicillin/Gentamicin; 5 mg/kg as a single dose of Gentamicin within 60 minutes prior to surgical incision; given in combination with 2 grams of ampicillin in cases where allergic to fluoroquinolone and cephalosporin; Other Names: Penicillinase-sensitive penicillin\Aminoglycoside
Active Comparator: Continued antibiotics; Continued antibiotics until the removal of any external catheters Intervention drug to be determined based on patient history etc.	Drug: cephalosporins; Patients were randomly assigned to the interventional arm or the control arm through stratified randomization. In addition to perioperative antibiotics, those in the interventional arm only received antibiotic course for up to 24 hours after procedure, while those in the control arm received antibiotics until external catheters were removed based on surgeon preference. Ancef, a 1st generation cephalosporin, was used as the primary antibiotic, which was started within 60 minutes of the procedure. Dosing was 1 gram IV every 8 hours and was adjusted for renal dosing as needed; Other Names: ancef; Drug: Fluoroquinolones; If the patient has an allergy to penicillin or cephalosporin, then Ciprofloxacin was used instead and started within 120 minutes of the procedure at 400mg IV and would be continued every 12hrs if patient has a normal creatinine clearance; Other Names: ciprofloxacin; Drug: Clindamycin; If allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision.; Other Names: Lincosamides; Drug: Ampicillin/Gentamicin; 5 mg/kg as a single dose of Gentamicin within 60 minutes prior to surgical incision; given in combination with 2 grams of ampicillin in cases where allergic to fluoroquinolone and cephalosporin; Other Names: Penicillinase-sensitive penicillin\Aminoglycoside

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Infectious Complications	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.	0-30 days post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay (Days)	Length of Hospital Stay After Surgery (days)	0-30 days post operatively
Number of Participants With Associated Clavien Grade of Adverse Event	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.	0 to 30 days after surgery

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Zeph Okeke, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: October 15, 2015
• First Posted (Estimated): October 19, 2015

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Antibiotics; Kidney Stones; Percutaneous Nephrolithotomy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Calculi; Nephrolithiasis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Ampicillin; Clindamycin; Gentamicins; Ciprofloxacin; Fluoroquinolones; Penicillins; Cephalosporins; Lincosamides
• Other Study ID Numbers: 14-003