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A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])

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ClinicalTrials.gov Identifier: NCT02384200
Recruitment Status : Completed
First Posted : March 10, 2015
Results First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Mayo Clinic
University of British Columbia
The Cleveland Clinic
Duke University
Ohio State University
Dartmouth-Hitchcock Medical Center
Vanderbilt University
New York University
Information provided by (Responsible Party):
Roger L Sur, M.D., University of California, San Diego

Study Description
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Brief Summary:

When patients are going to have surgery to remove large kidney stones (percutaneous nephrolithotomy [PCNL]), it is not clear whether the patients benefit from a course of prophylactic preoperative oral antibiotics; currently both the use of prophylactic preoperative oral antibiotics and no prophylactic oral antibiotics are considered to be within standard-of-care.

This study will randomize patients to preoperative prophylactic antibiotics or no antibiotics to determine if the use of preoperative prophylactic antibiotics decreases the postoperative risk of localized urinary tract infection (UTI) and/or systemic infection that started in the urinary tract (sepsis or urosepsis).


Condition or disease Intervention/treatment Phase
Nephrolithiasis Urinary Tract Infections Drug: nitrofurantoin monohydrate/macrocrystalline capsules Drug: ampicillin Drug: gentamicin Drug: vancomycin Drug: ceftriaxone Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The EDGE Consortium: A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy: Part 1
Actual Study Start Date : March 2015
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : June 1, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Antibiotic

1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily starting 1 week prior to planned kidney stone surgery (PCNL).

In addition, each patient receives a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.

 Drug: nitrofurantoin monohydrate/macrocrystalline capsules
1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily
Other Name: Macrobid

Drug: ampicillin
IV (2 g)

Drug: gentamicin
IV (5 mg/kg)

Drug: vancomycin
IV (1 g)

Drug: ceftriaxone
IV (2 g)
Active Comparator: No preoperative oral antibiotics
Each patient does receive a a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with penicillin allergy will receive vancomycin IV (1 g) instead of ampicillin and patients with gentamicin/aminoglycoside allergy will receive ceftriaxone IV (2 g) instead of gentamicin.
 Drug: ampicillin
IV (2 g)

Drug: gentamicin
IV (5 mg/kg)

Drug: vancomycin
IV (1 g)

Drug: ceftriaxone
IV (2 g)


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants That Developed Sepsis After Surgery [ Time Frame: Within 7 days following day of surgery ]

    "Sepsis" will be defined by the 2012 International Guidelines for Management of Severe Sepsis and Septic Shock where 2 or more of the following variables are present and temporally associated

    • Temp > 38.3 C or <36 C
    • Heart Rate > 90/min (at least 12 hrs after surgery)
    • Respiratory Rate > 20/min (at least 12 hrs after surgery)
    • Altered mental status: defined as lack of orientation to either name, place, or time/date.
    • Systolic Blood Pressure (SBP) < 90 mmHg, Mean Arterial Pressure < 70 mmHg, or SBP decrease >40 mmHg in adults
    • WBC >12000 or < 4000


Secondary Outcome Measures :
  1. Participants With Positive Renal Pelvic Urine Culture [ Time Frame: once at time of surgery, within 10 minutes of obtaining percutaneous access to the kidney ]
    percutaneously taken renal pelvic urine culture

  2. Participants With Positive Kidney Stone Culture [ Time Frame: once, within 6 hours of start of surgery ]
    Kidney stone sent for culture

  3. Positive Bladder Urine Culture [ Time Frame: once, within 30 minutes of start of surgery ]
    bladder urine culture taken during kidney stone surgery

  4. Number of Participants With Postoperative Urinary Tract Infection (UTI) [ Time Frame: Within 12 weeks following day of surgery ]
    symptomatic urinary tract infection

  5. Number of Participants With a Postoperative Fever Greater Than 38.3 Celsius [ Time Frame: within 7 days following day of surgery ]
    Body temperature >= 38.3 degrees Celsius

  6. Number of Participants Admitted to Intensive Care Unit (ICU) After Surgery [ Time Frame: within 7 days following day of surgery ]
    admission to ICU level nursing unit during primary hospitalization following kidney stone surgery (PCNL).

  7. Number and Grade of Postoperative Complications Following Surgery as Graded by the Clavien-Dindo Complication Scale [ Time Frame: Within 12 weeks following day of surgery ]
    The Clavien-Dindo grading scale, originally described in 2004, is a widely used throughout surgery to grade adverse events (i.e. complications) which occur as a result of surgical procedures; it is used in most urology units and has become the standard classification system for many surgical specialities. The grading system uses a Grade I - Grade V scale, with Grade V being the most severe.

  8. Hospital Length of Stay After Surgery [ Time Frame: Within 12 weeks following day of surgery ]
    Number of days in a hospital setting after kidney stone surgery (defined as number of midnights in hospitalization)

  9. Number of Partcipants That Were Stone Free After Surgery [ Time Frame: Within 12 weeks following day of surgery ]
    the absence of stone fragments >2mm on postoperative imaging following kidney stone surgery (PCNL)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 > =2cm in largest dimension) preoperatively as judged on CT scan, abdominal X-ray, ultrasound, or fluoroscopy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384200


Locations
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United States, Arizona
Mayo Clinic in Arizona
Phoenix, Arizona, United States, 85054
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
UCSF
San Francisco, California, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43212
United States, Tennessee
Vanderbilt
Nashville, Tennessee, United States, 37232-2765
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of California, San Diego
Mayo Clinic
University of British Columbia
The Cleveland Clinic
Duke University
Ohio State University
Dartmouth-Hitchcock Medical Center
Vanderbilt University
New York University
Investigators
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Principal Investigator: Roger L Sur, MD University of California, San Diego
Study Director: Daniel L Miller, MD MPH University of California, San Diego
  Study Documents (Full-Text)

Documents provided by Roger L Sur, M.D., University of California, San Diego:
Study Protocol and Statistical Analysis Plan  [PDF] July 3, 2016

More Information
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Publications:

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Responsible Party: Roger L Sur, M.D., Fellow, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02384200     History of Changes
Obsolete Identifiers: NCT02408211
Other Study ID Numbers: 160405
150013 ( Other Identifier: University of California San Diego )
First Posted: March 10, 2015    Key Record Dates
Results First Posted: August 22, 2019
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Urinary Tract Infections
Nephrolithiasis
Kidney Calculi
Infection
Urologic Diseases
Kidney Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Vancomycin
 Gentamicins
Ceftriaxone
Ampicillin
Nitrofurantoin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents