Kidney Stones
Conditions
Keywords
Percutaneous Nephrolithotomy, Kidney Stones, Antibiotics
Brief summary
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.
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
Interventions
DRUGcephalosporins
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
DRUGFluoroquinolones
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
DRUGClindamycin
If allergic to penicillin, cephalosporins, and fluoroquinolones, 900 mg Clindamycin started within 60 minutes prior to initial surgical incision.
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
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Infectious Complications | 0-30 days post-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay (Days) | 0-30 days post operatively | Length of Hospital Stay After Surgery (days) |
| Number of Participants With Associated Clavien Grade of Adverse Event | 0 to 30 days after surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Antibiotics for a 24 Hour Period Antibiotics for a 24 hour period
Intervention drug to be determined based on patient history etc.
cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication
aminoglycoside
metronidazole
Clindamycin
aminoglycoside/ sulbactam: If allergies to above medicines
Fluoroquinolones | 49 |
| Continued Antibiotics Continued antibiotics until the removal of any external catheters
Intervention drug to be determined based on patient history etc.
cephalosporins: Looking at the same drugs and doses the variable is the timeframe of the medication
aminoglycoside
metronidazole
Clindamycin
aminoglycoside/ sulbactam: If allergies to above medicines
Fluoroquinolones | 49 |
| Total | 98 |
Baseline characteristics
| Characteristic | Antibiotics for a 24 Hour Period | Continued Antibiotics | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 18 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 31 Participants | 68 Participants |
| Age, Continuous | 57.1 years STANDARD_DEVIATION 11.3 | 59.7 years STANDARD_DEVIATION 11.9 | 58.9 years STANDARD_DEVIATION 11.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 49 participants | 49 participants | 98 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 36 Participants | 36 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 9 / 49 | 10 / 49 |
| serious Total, serious adverse events | 1 / 49 | 2 / 49 |
Outcome results
Primary
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.
Time frame: 0-30 days post-operatively
Population: 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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antibiotics for a 24 Hour Period | Number of Participants With Infectious Complications | Fever | 6 Participants |
| Antibiotics for a 24 Hour Period | Number of Participants With Infectious Complications | SIRS | 6 Participants |
| Antibiotics for a 24 Hour Period | Number of Participants With Infectious Complications | Bacteriuria | 1 Participants |
| Antibiotics for a 24 Hour Period | Number of Participants With Infectious Complications | Bacteremia | 1 Participants |
| Continued Antibiotics | Number of Participants With Infectious Complications | Bacteremia | 1 Participants |
| Continued Antibiotics | Number of Participants With Infectious Complications | Fever | 7 Participants |
| Continued Antibiotics | Number of Participants With Infectious Complications | Bacteriuria | 2 Participants |
| Continued Antibiotics | Number of Participants With Infectious Complications | SIRS | 8 Participants |
Secondary
Length of Stay (Days)
Length of Hospital Stay After Surgery (days)
Time frame: 0-30 days post operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antibiotics for a 24 Hour Period | Length of Stay (Days) | 1.7 Days | Standard Deviation 0.8 |
| Continued Antibiotics | Length of Stay (Days) | 1.5 Days | Standard Deviation 1.9 |
Secondary
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.
Time frame: 0 to 30 days after surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Antibiotics for a 24 Hour Period | Number of Participants With Associated Clavien Grade of Adverse Event | Grade I | 4 Participants |
| Antibiotics for a 24 Hour Period | Number of Participants With Associated Clavien Grade of Adverse Event | Grade II | 2 Participants |
| Antibiotics for a 24 Hour Period | Number of Participants With Associated Clavien Grade of Adverse Event | Grade IIIA | 3 Participants |
| Antibiotics for a 24 Hour Period | Number of Participants With Associated Clavien Grade of Adverse Event | Grade IIIB | 1 Participants |
| Continued Antibiotics | Number of Participants With Associated Clavien Grade of Adverse Event | Grade IIIB | 2 Participants |
| Continued Antibiotics | Number of Participants With Associated Clavien Grade of Adverse Event | Grade I | 3 Participants |
| Continued Antibiotics | Number of Participants With Associated Clavien Grade of Adverse Event | Grade IIIA | 2 Participants |
| Continued Antibiotics | Number of Participants With Associated Clavien Grade of Adverse Event | Grade II | 5 Participants |