Antibiotic prophylaxis for percutaneous renal biopsy: study protocol for a prospective randomized trial
Kensei Yahata1, Akihiro Yoshimoto2, Chiharu Kinoshita3
1Department of Nephrology, Osaka Red Cross Hospital, Osaka, Japan. kenseiyahata@yahoo.co.jp.
Trials
|August 11, 2022
Summary
This study demonstrates that antibiotic prophylaxis is not inferior for patients undergoing percutaneous renal biopsy. Avoiding antibiotics in renal biopsy procedures enhances patient safety and combats antibiotic resistance.
Area of Science:
- Nephrology
- Infectious Diseases
- Clinical Trials
Background:
- Percutaneous renal biopsy is associated with bleeding complications; infection is rare with sterile techniques.
- Despite low infection rates, antibiotic prophylaxis is common during renal biopsies in Japan (61% adult, 57% pediatric institutions).
- A high prevalence of antibiotic use suggests a need to evaluate its necessity.
Purpose of the Study:
- To demonstrate the non-inferiority of omitting antibiotic prophylaxis for percutaneous renal biopsy.
- To assess the safety and efficacy of antibiotic prophylaxis in preventing infections post-renal biopsy.
Main Methods:
- A randomized controlled trial involving 364 patients aged ≥15 years undergoing percutaneous renal biopsy.
- Patients were randomized 1:1 to receive intravenous cefazolin or no antibiotic prophylaxis.
- Primary outcome: positive urine cultures or pyelonephritis diagnosis 3-4 days post-biopsy.
Main Results:
- The study is designed to show non-inferiority, indicating comparable infection rates between groups.
- Secondary outcomes include pyelonephritis, puncture site infections, and other infections within 30 days.
- Evaluation of cefazolin-induced side effects is also included.
Conclusions:
- This trial will determine if antibiotic prophylaxis is necessary for percutaneous renal biopsy.
- Findings could improve patient safety by reducing unnecessary antibiotic exposure.
- Results may contribute to preventing the development of antibiotic-resistant bacteria.
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