Phase 4
N=86
A Randomized Trial of Preoperative Prophylactic Antibiotics Prior to Kidney Stone Surgery (Percutaneous Nephrolithotomy [PCNL])
Nephrolithiasis · Urinary Tract Infections
Bottom Line
View on ClinicalTrials.gov: NCT02384200 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Number of Participants That Developed Sepsis After Surgery — 5; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- nitrofurantoin monohydrate/macrocrystalline capsules (Drug); ampicillin (Drug); gentamicin (Drug); vancomycin (Drug); ceftriaxone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Developed Sepsis After Surgery |
5; 6 | — |
| SECONDARY Participants With Positive Renal Pelvic Urine Culture |
1; 1 | — |
| SECONDARY Participants With Positive Kidney Stone Culture |
4; 4 | — |
| SECONDARY Positive Bladder Urine Culture |
1; 1 | — |
| SECONDARY Number of Participants With Postoperative Urinary Tract Infection (UTI) |
2; 0 | — |
| SECONDARY Number of Participants With a Postoperative Fever Greater Than 38.3 Celsius |
0; 1 | — |
| SECONDARY Number of Participants Admitted to Intensive Care Unit (ICU) After Surgery |
2; 0 | — |
| SECONDARY Number and Grade of Postoperative Complications Following Surgery as Graded by the Clavien-Dindo Complication Scale |
8; 4; 3; 5; 0; 1 | — |
| SECONDARY Hospital Length of Stay After Surgery |
1.097; 1.467 | — |
| SECONDARY Number of Partcipants That Were Stone Free After Surgery |
22; 25 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Renal stone of any size for which PCNL is recommended
Exclusion Criteria
- eGFR =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.
Data sourced from ClinicalTrials.gov (NCT02384200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.