A Study of the Use of Preoperative Antibiotics Given Preventively Prior to Kidney Stone Surgery to Patients at Moderate Risk of Infection


About this study

The purpose of this study is to determine if the use of preoperative  antibiotics given to prevent infection actually decreases the postoperative risk in patients having surgery to remove kidney stones.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Renal stone of any size for which PCNL is recommended

Exclusion Criteria

  • eGFR < 60 mL/min/1.73 m2
  • Cirrhosis and/or hepatitis
  • Pregnancy
  • Positive preoperative urine culture within 2 weeks
  • 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 2 weeks prior to randomization
  • Severe hydronephrosis (defined by ≥ 2 cm in largest dimension) preoperatively as judged on CT scan, abdominal X-ray, ultrasound, or fluoroscopy

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitchell Humphreys, M.D.

Closed for enrollment

More information


  • The purpose of this study was to analyze the various risk factors for urosepsis following percutaneous nephrolithotomy (PNL) and to study the role of 1-week nitrofurantoin before PNL in reducing the risk of urosepsis. All patients undergoing PNL from April 2007 to November 2008 were prospectively included and grouped into four cohorts according to the following inclusion criteria: group A: stones ≤ 2.5 cm, no hydronephrosis, sterile urine; group B: diabetes mellitus, serum creatinine > 2 mg/dl, positive urine culture, stag horn stones, presence of nephrostomy or simultaneous bilateral PNL; group C: stones ≥ 2.5 cm and/or hydronephrosis, sterile urine; group D: similar to group C, but received nitrofurantoin 100 mg bid for 7 days before operation. Preoperative urine culture, intraoperative renal pelvic urine culture and stone cultures were obtained. Fever > 380°C and leukocyte counts > 12,000 were considered as systemic inflammatory response syndrome (SIRS). Endotoxemia was assessed in serum samples. A total of 205 patients were included in the study and grouped into four cohorts as group A (n = 50), group B (n = 54), group C (n = 53) and group D (n = 48). Overall 23% patients had positive renal pelvic urine and/or stone culture, 25% had endotoxemia and 34% developed SIRS. Female gender, chronic renal failure, anemia, hydronephrosis, stones larger than 2.5 cm and prolonged surgery were found to be risk factors associated with urosepsis. Nitrofurantoin prophylaxis resulted in decreased culture positivity (30.2 vs. 8.3%, odds ratio 0.36, p = 0.087), endotoxemia (41.9 vs. 17.5%, odds ratio 0.22, p = 0.001) and SIRS (49 vs. 19%, odds ratio 0.31, p = 0.01). In conclusion, female gender, chronic renal failure, anemia, hydronephrosis, stones larger than 2.5 cm and prolonged surgery were risk factors for urosepsis. Nitrofurantoin is beneficial in the prevention of endotoxemia and urosepsis especially in patients with larger stones and hydronephrosis. Read More on PubMed
  • Prior studies suggest that renal pelvic urine culture is a more accurate predictor of urosepsis. We prospectively determined the correlation between preoperative bladder urine cultures, intraoperative renal pelvis cultures and stone cultures in patients undergoing percutaneous nephrolithotomy. We also examined post-procedure risk factors for systemic inflammatory response syndrome. Read More on PubMed
  • To assess the current indications, perioperative morbidity, and stone-free outcomes for percutaneous nephrolithotomy (PCNL) worldwide. Read More on PubMed
  • To evaluate the role of nitrofurantoin (NFT) prophylaxis in a prospective randomized control study. Urosepsis is an important complication after percutaneous nephrolithotomy (PNL). Risk increases by around 4 times with larger stones and hydronephrosis (HDN). Read More on PubMed
  • Antimicrobial prophylaxis is the periprocedural systemic administration of an antimicrobial agent intended to reduce the risk of postprocedural local and systemic infections. The AUA convened a BPP Panel to formulate recommendations on the use of antimicrobial prophylaxis during urologic surgery. Read More on PubMed

Mayo Clinic Footer