Preoperative Antibiotic PNL Study

Kidney Stones Clinical Trial

Official title:

The EDGE Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy: Part 1

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02408211
• Other study ID #: H15-00256
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: March 31, 2015
• Last updated: March 21, 2016
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Percutaneous nephrolithotomy (PCNL) is a surgical procedure that is standard of care for the removal of large kidney stones. PCNL involves removal of the stone(s) from the kidney through a temporary tract that is percutaneously placed through the patient's back during surgery. There is a significant risk of urinary tract infection after PCNL but wide clinical variation in use of prophylactic antibiotics in the days leading up to surgery. For patients who had already agreed to undergo PCNL, we plan to randomize them either to 1 week of preoperative antibiotic prophylaxis plus < 24 hours of perioperative IV antibiotics or to < 24 hours of perioperative IV antibiotics only. We will then compare the rates of infectious complications following PCNL for the two groups.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• All subjects (Age =19 years) undergoing PCNL for any size stone can be potentially be included.

Exclusion Criteria:

• eGFR < 60 mL/min/1.73 m2

• Cirrhosis and/or hepatitis

• Pregnancy

• Positive preoperative urine culture within 3 months

• 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 3 months prior to randomization

• Severe hydronephrosis (defined by = 2cm in largest dimension) preoperatively as judged on CT scan, abdominal X-ray, ultrasound, or fluoroscopy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Renal Calculi

Intervention

Drug:
• nitrofurantoin monohydrate/macrocrystalline
Nitrofurantoin monohydrate/macrocrystalline is currently indicated for the treatment of acute uncomplicated urinary tract infections. antibiotic
• ampicillin
IV 2 g
• gentamicin or vancomycin /ceftriaxone
gentamicin IV (5 mg/kg) (or vancomycin(1 g) /ceftriaxone (2 g)

Locations

Country	Name	City	State
Canada	The Stone Centre, VGH/UBC	Vancouver	British Columbia
United States	Ohio State University	Athens	Ohio
United States	Johns Hopkins University	Baltimore	Maryland
United States	Harvard University - Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	Dartmouth University	Lebanon	New Hampshire
United States	Vanderbilt University	Nashville	Tennessee
United States	New York University	New York	New York
United States	Mayo Clinic - Rochester, MN	Rochester	Minnesota
United States	Mayo Clinic - Scottsdale/Phoenix, AZ	Scottsdale	Arizona

Sponsors (11)

Lead Sponsor	Collaborator
University of British Columbia	Dartmouth-Hitchcock Medical Center, Duke University, Johns Hopkins University, Massachusetts General Hospital, Mayo Clinic, New York University, Ohio State University, San Diego State University, The Cleveland Clinic, Vanderbilt University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of postoperative sepsis	The patient will be discharged from the hospital per the usual clinical protocols. Post-discharge the patient will be seen in clinic 1-12 weeks after surgery. Patients will undergo a non-contrast CT abdomen/pelvis, an abdominal plain radiograph, and/or a renal ultrasound during this postoperative period.	12 weeks	No
Secondary	rate of nonseptic bacteruria		12 weeks	No
Secondary	stone-free rate		12 weeks	No
Secondary	Lenght of Stay (LOS)		12 weeks	No