Kidney Stones Clinical Trial
Official title:
The EDGE Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy: Part 1
Verified date | March 2016 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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 |
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 |
United States, Canada,
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 |
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