Antibiotic Prophylaxis for Percutaneous Renal Biopsy: Study Protocol for a Prospective Randomized Trial

Antibiotic Prophylaxis for Percutaneous Renal Biopsy: Study Protocol for a Prospective Randomized Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Antibiotic Prophylaxis for Percutaneous Renal Biopsy: Study Protocol for a Prospective Randomized Trial Kensei Yahata, Akihiro Yoshimoto, Chiharu Kinoshita, Koichi Seta, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-1182710/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 6 You are reading this latest preprint version Abstract • Background : The major complication of renal biopsy is bleeding. Infection is an extremely rare complication of percutaneous renal biopsy, providing sterile techniques are used and bowel perforation does not occur. However, the questionnaire included in the Kidney Biopsy Guidebook 2020 in Japan reported that antibiotic prophylaxis was administered to patients undergoing percutaneous renal biopsy at 61% of 170 adult institutions and 57% of 54 pediatric institutions. The objective of this study is to show the non-inferiority of not administering prophylactic antibiotics for percutaneous renal biopsy. • Methods : Patients aged ≥15 years who are scheduled to undergo percutaneous renal biopsy are eligible for inclusion in the study. Three hundred and sixty-four patients will be recruited at 6 hospitals. The patients will be randomly assigned at a 1:1 ratio to receive either a single dose of intravenous cefazolin (1 g) or no prophylactic antibiotics. The primary outcome is the number of patients that exhibit positive urine cultures (>10 5 colony-forming units/ml) 3 or 4 days after the renal biopsy, at which point the patients are diagnosed with pyelonephritis until 3 or 4 days after the renal biopsy. The secondary outcomes are the number of patients who are diagnosed with pyelonephritis within 30 days after the renal biopsy, the number of patients who are diagnosed with puncture site infections within 30 days after the renal biopsy, the number of patients who are diagnosed with an infection other than pyelonephritis or a puncture site infection within 30 days after the renal biopsy, and the number of patients who experience cefazolin-induced side effects. • Discussion : This randomized controlled trial aims to show the non-inferiority of not administering prophylactic antibiotics for percutaneous renal biopsy. If this study shows that antibiotic prophylaxis is not needed, it would help to ensure patient safety and prevent the development of antibiotic-resistant bacteria. • Trial registration : UMIN000042378 [UMIN Clinical Trials Registry (UMIN-CTR)] http://www.umin.ac.jp/ctr [Registered on 7/Nov/2020] Antibiotic prophylaxis Percutaneous renal biopsy Randomized controlled trial Introduction Background and rationale {6a} Renal biopsy is the most important technique in the field of nephrology and is used to pathologically diagnose renal disease, estimate prognoses and the effects of treatment, and determine the optimal treatment strategy. The major complication of renal biopsy is bleeding. On the other hand, infection is an extremely rare complication of percutaneous renal biopsy, providing a sterile technique is used and bowel perforation does not occur [ 1 ]. However, the questionnaire included in the Kidney Biopsy Guidebook 2020 in Japan showed that antibiotic prophylaxis was administered to patients undergoing percutaneous renal biopsy at 61% of 170 adult institutions and 57% of 54 pediatric institutions [ 2 ]. The guidelines developed jointly by the American Society of Health-System Pharmacists (ASHP), the Infectious Diseases Society of America (IDSA), the Surgical Infection Society (SIS), and the Society for Healthcare Epidemiology of America (SHEA) included policies relating to the administration of antibiotic prophylaxis in various types of surgery [ 3 ]. According to these guidelines, the use of antibiotic prophylaxis is not recommended for some types of clean and low-infectious-risk surgery. In addition, it is stated that postoperative antimicrobial treatment is not necessary after most procedures, and the duration of antimicrobial prophylaxis should be less than 24 hours for most procedures. The 2017 Centers of Disease Control and Prevention guidelines recommend that antibiotic prophylaxis should ensure that bactericidal concentrations of the antibiotic are achieved in blood and tissue before a skin incision is made [ 4 ]. Moreover, it is stated that antibiotic prophylaxis should not be administered after an incision has been closed in clean surgery. The World Health Organization guidelines state that antibiotic prophylaxis should be administered within 120 minutes before skin incisions, and they oppose the continuing administration of antibiotic prophylaxis after surgery [ 5 ]. The questionnaire included in the Kidney Biopsy Guidebook 2020 in Japan did not examine the type or administration route of antibiotic prophylaxis, e.g., whether the drug was orally administered for several days or intravenously injected before the renal biopsy. In addition, no previous studies have examined the efficacy of antibiotic prophylaxis for percutaneous renal biopsies, regardless of the type or route of the prophylaxis. Objectives {7} The objective of this study was to show the non-inferiority of not administering prophylactic antibiotics for percutaneous renal biopsy. If this study shows that antibiotic prophylaxis is not needed for percutaneous renal biopsy, it would help to ensure patient safety and prevent the development of antibiotic-resistant bacteria. Trial design {8} This is a multicenter randomized controlled trial. The participants will be randomly assigned at a 1:1 ratio to receive either a single dose of intravenous cefazolin (1 g) or no prophylactic antibiotics (cefazolin versus no prophylaxis group). Methods: Participants, Interventions And Outcomes Study setting {9} This study will be performed at referral hospitals in Osaka, Kyoto, and Kobe that specialize in kidney disease. Patients will be recruited at these hospitals. Patients will be considered for inclusion if they meet the criteria outlined below. Eligibility criteria {10} Inclusion criteria • Patients who are aged ≥15 years who are scheduled to undergo percutaneous renal biopsy Exclusion criteria • Patients who present with a white blood cell count of >10/high-power field (HPF) on two occasions during the most recent urinalysis (including once within 3 days of the procedure) • Patients who are allergic to cefazolin • Patients who receive antibiotics in the 7 days before the renal biopsy • Patients who undergo urethral catheter insertion in the 7 days before the renal biopsy • Patients infected with human immunodeficiency virus • Pregnant patients Who will take informed consent? {26a} The operators who perform the percutaneous renal biopsies will identify eligible participants based upon the inclusion and exclusion criteria. Detailed written and oral information on the study will be provided to the patients, and the operators will obtain written informed consent. Additional consent provisions for collection and use of participant data and biological specimens {26b} Not applicable Interventions Explanation for the choice of comparators {6b} Cefazolin will be administered within 1 hour before the renal biopsy, and its administration will be ended before the renal biopsy. Intervention description {11a} No prophylactic antibiotics will be administered. Criteria for discontinuing or modifying allocated interventions {11b} Patients can leave the study at any time for any reason if they wish to do so without any consequences. Any patient data that have been collected up to that moment will be included in the analysis. When a side effect occurs during cefazolin administration, the administration of the drug will be discontinued. Patients that become ill will be asked to contact the primary investigator. Strategies to improve adherence to interventions {11c} Patients will remain in close contact with the operators, who will monitor their progression during study visits. If a patient does not come to the hospital as scheduled, we will contact them about their condition via telephone or a sealed letter. Relevant concomitant care permitted or prohibited during the trial {11d} Any care is permitted during the study. Provisions for post-trial care {30} This study does not have compensation insurance because it aims to show the non-inferiority of not administering prophylactic antibiotics. If the enforcement of this study causes a patient to develop a health hazard, it will be treated at the relevant hospital. The costs of the treatment of the health hazard will be borne by the patient’s health insurance. Outcomes {12} The primary outcome is the number of patients that exhibit positive urine cultures (>10 5 colony-forming units/ml) 3 or 4 days after the renal biopsy, at which point the patients are diagnosed with pyelonephritis until 3 or 4 days after the renal biopsy. The secondary outcomes of this study include the number of patients who are diagnosed with pyelonephritis within 30 days after the renal biopsy, the number of patients who are diagnosed with a puncture site infection within 30 days after the renal biopsy, the number of patients who are diagnosed with an infection other than pyelonephritis or a puncture site infection within 30 days after the renal biopsy, and the number of patients who experience cefazolin-induced side effects. Pyelonephritis is defined as a fever of >38 °C and a white blood cell count of >10/HPF according to urinalysis. Urine cultures will be conducted at diagnosis where possible. A puncture site infection is defined as the presence of purulent discharge, spontaneous pain, tenderness, swelling, redness, and/or a feeling of heat at the puncture site. When purulent discharge is present, a culture test will be conducted if possible. Participant timeline {13} Additional file is attached. Sample size {14} The study sample size was calculated in accordance with the 1:1 allocation rule. We anticipated that the urine culture positivity rate would be 1% and the non-inferior margin would be 3%. Assuming an alpha value of 0.05 and a beta value of 0.2 for a two-sided test, 346 cases are required in each group. It is expected that 5% of cases will be inadequate for the purposes of the study, and hence, the number of required cases was set at 364. Recruitment {15} Patients will be recruited at Osaka Red Cross Hospital, Kobe City Medical Center General Hospital, Kyoto Min-Iren Chuo Hospital, National Hospital Organization Kyoto Medical Center, Kitano Hospital, and Kyoto University Hospital. Over 200 percutaneous renal biopsies are carried out at these hospitals annually. Assignment of interventions: allocation Sequence generation {16a} Patients will be randomized to receive either a single dose of intravenous cefazolin (1 g) or no prophylactic antibiotics (1:1 ratio) using a stratified block allocation, with sex (male or female) being used as a stratification factor. Concealment mechanism {16b} Allocation is not concealed and will be revealed to both the patients and investigators upon randomization. Implementation {16c} After obtaining signed informed consent forms, the investigators will use the assignment list to allocate each patient to one of the study arms. The study group will be revealed at the same time to both the patients and investigators. Assignment of interventions: Blinding Who will be blinded {17a} The patients, investigators, and operators will not be blinded since this is impossible due to the difference between the two groups (cefazolin group versus no prophylaxis group). Procedure for unblinding if needed {17b} The study will have an open label design; therefore, there is no unblinding procedure. Data collection and management Plans for assessment and collection of outcomes {18a} All clinical data and patient-reported information will be entered into electronic case-record forms. The case-record forms can be obtained by emailing the corresponding author of this manuscript. Plans to promote participant retention and complete follow-up {18b} Patients will be in close contact with the operators, who will monitor their progression during study visits. If a patient does not come to the hospital as scheduled, we will contact them about their condition via telephone or a sealed letter. Data management {19} All data (case-record forms) will be stored in a password-protected computer in an electronic file for further analysis. All measures will be taken to create a backup of the stored data to prevent data loss. Confidentiality {27} The research data will be stored using a study identification code for each participant. The key to the identification code list will only be available to the research team during the study and will be documented and safeguarded by the principal investigator according to research guidelines after the completion of the study. No patient identification details will be reported in publications. Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} There are no plans to collect, evaluate, or store biological specimens for genetic or molecular analysis in this study. Statistical methods Statistical methods for primary and secondary outcomes {20a} The data will be analyzed using the statistical software “R”. Data regarding the primary objective (the number of patients with positive urine cultures) will be presented as categorical variables. In comparisons between the two groups, one-sided p-values for non-inferiority will be calculated using the Farrington-Manning test. Continuous variables will be tested for normality and expressed as x±s values for normally distributed variables or as median (interquartile range) values for non-normally distributed variables. Continuous variables will be compared using the independent t-test or Mann-Whitney U test. Categorical data will be expressed as rates or percentages. Inter-group comparisons will be performed using Fisher’s exact probability test. Two-sided tests will be used, with p-values of <0.05 considered to indicate a statistically significant difference. Interim analyses {21b} There are no interim analyses planned. Methods for additional analyses (e.g. subgroup analyses) {20b} A subgroup analysis in which the patients who underwent continuous or intermittent urinary catheterization just before or after the renal biopsy will be compared with those who did not undergo such catheterization will be performed. Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} The primary outcome will be assessed using an intention-to-treat analysis. Sensitivity analysis will be performed to deal with any missing data. If a statistical method is needed to account for missing data relating to the primary or secondary outcomes, multiple imputation will be used. Plans to give access to the full protocol, participant level-data and statistical code {31c} Reasonable access to the protocol and other documents can be gained by contacting the corresponding author. Oversight and monitoring Composition of the coordinating centre and trial steering committee {5d} Given the short period of the intervention and low risk of the trial, no coordinating center or trial steering committee will be formed. Composition of the data monitoring committee, its role and reporting structure {21a} Given the short period of the intervention and low risk of the trial, no data monitoring committee will be formed. Adverse event reporting and harms {22} An adverse event is defined as any untoward medical occurrence in a clinical investigation patient with or without an association with the study. A serious adverse event is defined as any untoward medical occurrence at any dose that: • Results in death or • Is life-threatening or • Requires inpatient hospitalization or the prolongation of current hospitalization or • Results in persistent or significant disability/incapacity or • Is a medically important event Medical and scientific judgment will be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These events will usually be considered serious. The investigator will evaluate any adverse events experienced by the patients and record them in a case report. If a sign (including laboratory values) or symptom is included within a particular diagnosis, the diagnosis will be recorded rather than individual signs and symptoms, where possible. For all patients registered in this study, all adverse events that develop will be recorded and monitored until they are treated or until the end of the observation period. When an adverse event develops, the investigator will give the patient adequate treatment promptly and follow them up until recovery or relief is confirmed. Frequency and plans for auditing trial conduct {23} Independent data monitoring and auditing are not considered necessary because this is a low-risk intervention. Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} The investigators, ethical review board, and regulators will be notified of any important modifications to the protocol. Dissemination plans {31a} The results of this study will be disclosed completely in an international peer-reviewed journal. Both positive and negative results will be reported. Patients will receive a layman’s summary of the results if they opt-in to receive study-level outcomes. Discussion This randomized controlled trial aims to show the non-inferiority of not administering prophylactic antibiotics for percutaneous renal biopsy. If this study shows that antibiotic prophylaxis is not needed, it would help to ensure patient safety and prevent the development of antibiotic-resistant bacteria. There have been few studies about infections related to renal biopsy. One study examined the complications associated with 1812 renal biopsies conducted over 37 years [ 6 ]. Urinary tract infection followed gross hematuria in 2 patients and was attributed to vigorous irrigation to remove clots from the bladder. Both patients recovered. Another patient developed transient bacteremia with chills, fever, and hypotension following perforation of the colon during a biopsy. The patient recovered with no further difficulty [ 6 ]. Some other more previous cases of infection after a renal biopsy have also been reported. These patients had pyelonephritis before the renal biopsy [ 7 , 8 ]. Catheter-associated urinary tract infections (CAUTI) are the most common type of healthcare-associated infection. There was a marked reduction in risk of bacteriuria after the introduction of sterile, closed urinary drainage systems in the 1960s [ 9 ]. However, even when a closed drainage system is used, bacteriuria inevitably occurs over time either via breaks in the sterile system or via the extraluminal route. The daily risk of bacteriuria during catheterization is 3–10%, and approaches 100% after 30 days [ 9 ]. The causative pathogens of CAUTI include Escherichia coli , Candida spp, and Enterococcus spp [ 9 ]. These pathogens may be different from the sources of infection for percutaneous renal biopsy-associated infections. Therefore, a subgroup analysis in which the patients who underwent continuous or intermittent urinary catheterization just before or after the renal biopsy will be compared with those who did not undergo such catheterization will be performed. Trial status Recruiting started in November 2020. The current protocol is version 2 of 15/Nov/2021. It is estimated that patient recruitment will be completed around March 2023. Abbreviations CAUTI: Catheter-associated urinary tract infections HPF: High-power field Declarations Acknowledgements Not applicable Authors’ contributions {31b} KY is primarily responsible for the study conception, design, and analysis plan. AY, CK, KS, TT, and MY contributed to the trial design, intervention, outcome measures, and data collection process. HH contributed to the study design, the power size calculation, and the development of the proposal. NS produced the statistical analysis plan and will perform the final study analysis. All of the authors have read and approved the final manuscript. Funding {4} This trial was funded by Osaka Red Cross Hospital and National Hospital Organization Kyoto Medical Center. The funders do not have any role in the collection, analysis, or interpretation of the data, or in the writing of the manuscript. Availability of data and materials {29} The datasets used and/or analysed during the current study will be made available from the corresponding author upon reasonable request. Ethics approval and consent to participate {24} Ethical approval was granted by each of the participating institutions. All participating patients will provide written informed consent. Consent for publication {32} This manuscript does not contain individual personal data from patients. Competing interests {28} The authors declare that they have no competing interests. References Hogan JJ, Mocanu M, Berns JS. The Native Kidney Biopsy: Update and Evidence for Best Practice. Clin J Am Soc Nephrol . 2016;11:354-62 Kidney biopsy guidebook 2020 in Japan questionnaire. In: Committee of Practical Guide for Kidney Biopsy 2020 in Japanese Society of Nephrology, editors. Kidney biopsy guidebook 2020 in Japan. Tokyo: Tokyo Igakusha; 2020. p. 115 (in Japanese) Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm . 2013;70:195-283 Berríos-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg . 2017;152:784-91 Optimal timing for preoperative surgical antibiotic prophylaxis. In: Global Guidelines for the Prevention of Surgical Site Infection. Geneva: © World Health Organization 2016; 2016. p. 71-5 Parrish AE. Complications of percutaneous renal biopsy: a review of 37 years' experience. Clin Nephrol . 1992;38:135-41 Kark RM, Muehrcke RC, Pollak VE, Pirani CL, Kiefer JH. An analysis of five hundred percutaneous renal biopsies. AMA Arch Intern Med . 1958;101:439-51 Lee DA, Roger R, Agre KM, Rubini M. Late complications of percutaneous renal biopsy. J Urol . 1967;97:793-7 Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol . 2010;31:319-26 Supplementary Files Participanttimeline2021.12.12.xlsx Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Major revision 26 Jun, 2022 Reviewers agreed at journal 20 Jun, 2022 Reviews received at journal 15 Mar, 2022 Reviewers invited by journal 14 Mar, 2022 Editor assigned by journal 05 Mar, 2022 First submitted to journal 17 Dec, 2021 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-1182710","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":90688089,"identity":"a240905c-10cb-4e0f-a692-550a38dad385","order_by":0,"name":"Kensei 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id=\"Sec2\"\u003e\n \u003cp\u003e\u003cstrong\u003eBackground and rationale {6a}\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003eRenal biopsy is the most important technique in the field of nephrology and is used to pathologically diagnose renal disease, estimate prognoses and the effects of treatment, and determine the optimal treatment strategy. The major complication of renal biopsy is bleeding. On the other hand, infection is an extremely rare complication of percutaneous renal biopsy, providing a sterile technique is used and bowel perforation does not occur [\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e]. However, the questionnaire included in the Kidney Biopsy Guidebook 2020 in Japan showed that antibiotic prophylaxis was administered to patients undergoing percutaneous renal biopsy at 61% of 170 adult institutions and 57% of 54 pediatric institutions [\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e\n \u003cp\u003eThe guidelines developed jointly by the American Society of Health-System Pharmacists (ASHP), the Infectious Diseases Society of America (IDSA), the Surgical Infection Society (SIS), and the Society for Healthcare Epidemiology of America (SHEA) included policies relating to the administration of antibiotic prophylaxis in various types of surgery [\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e]. According to these guidelines, the use of antibiotic prophylaxis is not recommended for some types of clean and low-infectious-risk surgery. In addition, it is stated that postoperative antimicrobial treatment is not necessary after most procedures, and the duration of antimicrobial prophylaxis should be less than 24 hours for most procedures. The 2017 Centers of Disease Control and Prevention guidelines recommend that antibiotic prophylaxis should ensure that bactericidal concentrations of the antibiotic are achieved in blood and tissue before a skin incision is made [\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e]. Moreover, it is stated that antibiotic prophylaxis should not be administered after an incision has been closed in clean surgery. The World Health Organization guidelines state that antibiotic prophylaxis should be administered within 120 minutes before skin incisions, and they oppose the continuing administration of antibiotic prophylaxis after surgery [\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e\n \u003cp\u003eThe questionnaire included in the Kidney Biopsy Guidebook 2020 in Japan did not examine the type or administration route of antibiotic prophylaxis, e.g., whether the drug was orally administered for several days or intravenously injected before the renal biopsy. In addition, no previous studies have examined the efficacy of antibiotic prophylaxis for percutaneous renal biopsies, regardless of the type or route of the prophylaxis.\u003c/p\u003e\n\u003c/div\u003e\n\u003cp\u003e\u003cstrong\u003eObjectives {7}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe objective of this study was to show the non-inferiority of not administering prophylactic antibiotics for percutaneous renal biopsy. If this study shows that antibiotic prophylaxis is not needed for percutaneous renal biopsy, it would help to ensure patient safety and prevent the development of antibiotic-resistant bacteria.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial design {8}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis is a multicenter randomized controlled trial. The participants will be randomly assigned at a 1:1 ratio to receive either a single dose of intravenous cefazolin (1 g) or no prophylactic antibiotics (cefazolin versus no prophylaxis group).\u003c/p\u003e"},{"header":"Methods: Participants, Interventions And Outcomes","content":"\u003cp\u003e\u003cstrong\u003eStudy setting {9}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study will be performed at referral hospitals in Osaka, Kyoto, and Kobe that specialize in kidney disease. Patients will be recruited at these hospitals. Patients will be considered for inclusion if they meet the criteria outlined below.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEligibility criteria {10}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInclusion criteria\u003c/p\u003e\n\u003cp\u003e\u0026bull; Patients who are aged \u0026ge;15 years who are scheduled to undergo percutaneous renal biopsy\u003c/p\u003e\n\u003cp\u003eExclusion criteria\u003c/p\u003e\n\u003cp\u003e\u0026bull; Patients who present with a white blood cell count of \u0026gt;10/high-power field (HPF) on two occasions during the most recent urinalysis (including once within 3 days of the procedure)\u003c/p\u003e\n\u003cp\u003e\u0026bull; Patients who are allergic to cefazolin\u003c/p\u003e\n\u003cp\u003e\u0026bull; Patients who receive antibiotics in the 7 days before the renal biopsy\u003c/p\u003e\n\u003cp\u003e\u0026bull; Patients who undergo urethral catheter insertion in the 7 days before the renal biopsy\u003c/p\u003e\n\u003cp\u003e\u0026bull; Patients infected with human immunodeficiency virus\u003c/p\u003e\n\u003cp\u003e\u0026bull; Pregnant patients\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho will take informed consent? {26a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe operators who perform the percutaneous renal biopsies will identify eligible participants based upon the inclusion and exclusion criteria. Detailed written and oral information on the study will be provided to the patients, and the operators will obtain written informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdditional consent provisions for collection and use of participant data and biological specimens {26b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterventions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExplanation for the choice of comparators {6b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCefazolin will be administered within 1 hour before the renal biopsy, and its administration will be ended before the renal biopsy.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention description {11a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo prophylactic antibiotics will be administered.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCriteria for discontinuing or modifying allocated interventions {11b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients can leave the study at any time for any reason if they wish to do so without any consequences. Any patient data that have been collected up to that moment will be included in the analysis. When a side effect occurs during cefazolin administration, the administration of the drug will be discontinued. Patients that become ill will be asked to contact the primary investigator.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStrategies to improve adherence to interventions {11c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients will remain in close contact with the operators, who will monitor their progression during study visits. If a patient does not come to the hospital as scheduled, we will contact them about their condition via telephone or a sealed letter.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRelevant concomitant care permitted or prohibited during the trial {11d}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAny care is permitted during the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProvisions for post-trial care {30}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study does not have compensation insurance because it aims to show the non-inferiority of not administering prophylactic antibiotics. If the enforcement of this study causes a patient to develop a health hazard, it will be treated at the relevant hospital. The costs of the treatment of the health hazard will be borne by the patient\u0026rsquo;s health insurance.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcomes {12}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary outcome is the number of patients that exhibit positive urine cultures (\u0026gt;10\u003csup\u003e5\u003c/sup\u003e colony-forming units/ml) 3 or 4 days after the renal biopsy, at which point the patients are diagnosed with pyelonephritis until 3 or 4 days after the renal biopsy. The secondary outcomes of this study include the number of patients who are diagnosed with pyelonephritis within 30 days after the renal biopsy, the number of patients who are diagnosed with a puncture site infection within 30 days after the renal biopsy, the number of patients who are diagnosed with an infection other than pyelonephritis or a puncture site infection within 30 days after the renal biopsy, and the number of patients who experience cefazolin-induced side effects.\u003c/p\u003e\n\u003cp\u003ePyelonephritis is defined as a fever of \u0026gt;38 \u0026deg;C and a white blood cell count of \u0026gt;10/HPF according to urinalysis. Urine cultures will be conducted at diagnosis where possible. A puncture site infection is defined as the presence of purulent discharge, spontaneous pain, tenderness, swelling, redness, and/or a feeling of heat at the puncture site. When purulent discharge is present, a culture test will be conducted if possible.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipant timeline {13}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAdditional file is attached.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size {14}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study sample size was calculated in accordance with the 1:1 allocation rule. We anticipated that the urine culture positivity rate would be 1% and the non-inferior margin would be 3%. Assuming an alpha value of 0.05 and a beta value of 0.2 for a two-sided test, 346 cases are required in each group. It is expected that 5% of cases will be inadequate for the purposes of the study, and hence, the number of required cases was set at 364.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment {15}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients will be recruited at Osaka Red Cross Hospital, Kobe City Medical Center General Hospital, Kyoto Min-Iren Chuo Hospital, National Hospital Organization Kyoto Medical Center, Kitano Hospital, and Kyoto University Hospital. Over 200 percutaneous renal biopsies are carried out at these hospitals annually.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssignment of interventions: allocation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSequence generation {16a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients will be randomized to receive either a single dose of intravenous cefazolin (1 g) or no prophylactic antibiotics (1:1 ratio) using a stratified block allocation, with sex (male or female) being used as a stratification factor.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConcealment mechanism {16b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAllocation is not concealed and will be revealed to both the patients and investigators upon randomization.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eImplementation {16c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAfter obtaining signed informed consent forms, the investigators will use the assignment list to allocate each patient to one of the study arms. The study group will be revealed at the same time to both the patients and investigators.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssignment of interventions: Blinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho will be blinded {17a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe patients, investigators, and operators will not be blinded since this is impossible due to the difference between the two groups (cefazolin group versus no prophylaxis group).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProcedure for unblinding if needed {17b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study will have an open label design; therefore, there is no unblinding procedure.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData collection and management\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for assessment and collection of outcomes {18a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll clinical data and patient-reported information will be entered into electronic case-record forms. The case-record forms can be obtained by emailing the corresponding author of this manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans to promote participant retention and complete follow-up {18b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients will be in close contact with the operators, who will monitor their progression during study visits. If a patient does not come to the hospital as scheduled, we will contact them about their condition via telephone or a sealed letter.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData management {19}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll data (case-record forms) will be stored in a password-protected computer in an electronic file for further analysis. All measures will be taken to create a backup of the stored data to prevent data loss.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConfidentiality {27}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe research data will be stored using a study identification code for each participant. The key to the identification code list will only be available to the research team during the study and will be documented and safeguarded by the principal investigator according to research guidelines after the completion of the study. No patient identification details will be reported in publications.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere are no plans to collect, evaluate, or store biological specimens for genetic or molecular analysis in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods for primary and secondary outcomes {20a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data will be analyzed using the statistical software \u0026ldquo;R\u0026rdquo;. Data regarding the primary objective (the number of patients with positive urine cultures) will be presented as categorical variables. In comparisons between the two groups, one-sided p-values for non-inferiority will be calculated using the Farrington-Manning test. Continuous variables will be tested for normality and expressed as x\u0026plusmn;s values for normally distributed variables or as median (interquartile range) values for non-normally distributed variables. Continuous variables will be compared using the independent t-test or Mann-Whitney U test. Categorical data will be expressed as rates or percentages. Inter-group comparisons will be performed using Fisher\u0026rsquo;s exact probability test. Two-sided tests will be used, with p-values of \u0026lt;0.05 considered to indicate a statistically significant difference.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterim analyses {21b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere are no interim analyses planned.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods for additional analyses (e.g. subgroup analyses) {20b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA subgroup analysis in which the patients who underwent continuous or intermittent urinary catheterization just before or after the renal biopsy will be compared with those who did not undergo such catheterization will be performed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary outcome will be assessed using an intention-to-treat analysis. Sensitivity analysis will be performed to deal with any missing data. If a statistical method is needed to account for missing data relating to the primary or secondary outcomes, multiple imputation will be used.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans to give access to the full protocol, participant level-data and statistical code {31c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eReasonable access to the protocol and other documents can be gained by contacting the corresponding author.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOversight and monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eComposition of the coordinating centre and trial steering committee {5d}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGiven the short period of the intervention and low risk of the trial, no coordinating center or trial steering committee will be formed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eComposition of the data monitoring committee, its role and reporting structure {21a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGiven the short period of the intervention and low risk of the trial, no data monitoring committee will be formed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdverse event reporting and harms {22}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAn adverse event is defined as any untoward medical occurrence in a clinical investigation patient with or without an association with the study.\u003c/p\u003e\n\u003cp\u003eA serious adverse event is defined as any untoward medical occurrence at any dose that:\u003c/p\u003e\n\u003cp\u003e\u0026bull; Results in death or\u003c/p\u003e\n\u003cp\u003e\u0026bull; Is life-threatening or\u003c/p\u003e\n\u003cp\u003e\u0026bull; Requires inpatient hospitalization or the prolongation of current hospitalization or\u003c/p\u003e\n\u003cp\u003e\u0026bull; Results in persistent or significant disability/incapacity or\u003c/p\u003e\n\u003cp\u003e\u0026bull; Is a medically important event\u003c/p\u003e\n\u003cp\u003eMedical and scientific judgment will be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in the definition above. These events will usually be considered serious.\u003c/p\u003e\n\u003cp\u003eThe investigator will evaluate any adverse events experienced by the patients and record them in a case report. If a sign (including laboratory values) or symptom is included within a particular diagnosis, the diagnosis will be recorded rather than individual signs and symptoms, where possible.\u003c/p\u003e\n\u003cp\u003eFor all patients registered in this study, all adverse events that develop will be recorded and monitored until they are treated or until the end of the observation period.\u003c/p\u003e\n\u003cp\u003eWhen an adverse event develops, the investigator will give the patient adequate treatment promptly and follow them up until recovery or relief is confirmed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFrequency and plans for auditing trial conduct {23}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIndependent data monitoring and auditing are not considered necessary because this is a low-risk intervention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe investigators, ethical review board, and regulators will be notified of any important modifications to the protocol.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination plans {31a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe results of this study will be disclosed completely in an international peer-reviewed journal. Both positive and negative results will be reported. Patients will receive a layman\u0026rsquo;s summary of the results if they opt-in to receive study-level outcomes.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis randomized controlled trial aims to show the non-inferiority of not administering prophylactic antibiotics for percutaneous renal biopsy. If this study shows that antibiotic prophylaxis is not needed, it would help to ensure patient safety and prevent the development of antibiotic-resistant bacteria.\u003c/p\u003e\n\u003cp\u003eThere have been few studies about infections related to renal biopsy. One study examined the complications associated with 1812 renal biopsies conducted over 37 years [\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e]. Urinary tract infection followed gross hematuria in 2 patients and was attributed to vigorous irrigation to remove clots from the bladder. Both patients recovered. Another patient developed transient bacteremia with chills, fever, and hypotension following perforation of the colon during a biopsy. The patient recovered with no further difficulty [\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e]. Some other more previous cases of infection after a renal biopsy have also been reported. These patients had pyelonephritis before the renal biopsy [\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e\n\u003cp\u003eCatheter-associated urinary tract infections (CAUTI) are the most common type of healthcare-associated infection. There was a marked reduction in risk of bacteriuria after the introduction of sterile, closed urinary drainage systems in the 1960s [\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e]. However, even when a closed drainage system is used, bacteriuria inevitably occurs over time either via breaks in the sterile system or via the extraluminal route. The daily risk of bacteriuria during catheterization is 3\u0026ndash;10%, and approaches 100% after 30 days [\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e]. The causative pathogens of CAUTI include \u003cem\u003eEscherichia coli\u003c/em\u003e, \u003cem\u003eCandida\u003c/em\u003e spp, and \u003cem\u003eEnterococcus\u003c/em\u003e spp [\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e]. These pathogens may be different from the sources of infection for percutaneous renal biopsy-associated infections. Therefore, a subgroup analysis in which the patients who underwent continuous or intermittent urinary catheterization just before or after the renal biopsy will be compared with those who did not undergo such catheterization will be performed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial status\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRecruiting started in November 2020. The current protocol is version 2 of 15/Nov/2021. It is estimated that patient recruitment will be completed around March 2023.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCAUTI: Catheter-associated urinary tract infections\u003c/p\u003e\n\u003cp\u003eHPF: High-power field\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions {31b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eKY is primarily responsible for the study conception, design, and analysis plan.\u003c/p\u003e\n\u003cp\u003eAY, CK, KS, TT, and MY contributed to the trial design, intervention, outcome measures, and data collection process.\u003c/p\u003e\n\u003cp\u003eHH contributed to the study design, the power size calculation, and the development of the proposal.\u003c/p\u003e\n\u003cp\u003eNS produced the statistical analysis plan and will perform the final study analysis.\u003c/p\u003e\n\u003cp\u003eAll of the authors have read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding {4}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis trial was funded by Osaka Red Cross Hospital and National Hospital Organization Kyoto Medical Center. The funders do not have any role in the collection, analysis, or interpretation of the data, or in the writing of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials {29}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analysed during the current study will be made available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate {24}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval was granted by each of the participating institutions. All participating patients will provide written informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication {32}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis manuscript does not contain individual personal data from patients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests {28}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eHogan JJ, Mocanu M, Berns JS. The Native Kidney Biopsy: Update and Evidence for Best Practice. Clin J Am Soc Nephrol\u003cem\u003e.\u003c/em\u003e 2016;11:354-62\u003c/li\u003e\n \u003cli\u003eKidney biopsy guidebook 2020 in Japan questionnaire. In: Committee of Practical Guide for Kidney Biopsy 2020 in Japanese Society of Nephrology, editors. Kidney biopsy guidebook 2020 in Japan. Tokyo: Tokyo Igakusha; 2020. p. 115 (in Japanese)\u003c/li\u003e\n \u003cli\u003eBratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm\u003cem\u003e.\u003c/em\u003e 2013;70:195-283\u003c/li\u003e\n \u003cli\u003eBerr\u0026iacute;os-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg\u003cem\u003e.\u003c/em\u003e 2017;152:784-91\u003c/li\u003e\n \u003cli\u003eOptimal timing for preoperative surgical antibiotic prophylaxis. In: Global Guidelines for the Prevention of Surgical Site Infection. Geneva: \u0026copy; World Health Organization 2016; 2016. p. 71-5\u003c/li\u003e\n \u003cli\u003eParrish AE. Complications of percutaneous renal biopsy: a review of 37 years\u0026apos; experience. Clin Nephrol\u003cem\u003e.\u003c/em\u003e 1992;38:135-41\u003c/li\u003e\n \u003cli\u003eKark RM, Muehrcke RC, Pollak VE, Pirani CL, Kiefer JH. An analysis of five hundred percutaneous renal biopsies. AMA Arch Intern Med\u003cem\u003e.\u003c/em\u003e 1958;101:439-51\u003c/li\u003e\n \u003cli\u003eLee DA, Roger R, Agre KM, Rubini M. Late complications of percutaneous renal biopsy. J Urol\u003cem\u003e.\u003c/em\u003e 1967;97:793-7\u003c/li\u003e\n \u003cli\u003eGould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol\u003cem\u003e.\u003c/em\u003e 2010;31:319-26\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Antibiotic prophylaxis, Percutaneous renal biopsy, Randomized controlled trial","lastPublishedDoi":"10.21203/rs.3.rs-1182710/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-1182710/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e•\u0026nbsp;\u003cstrong\u003eBackground\u003c/strong\u003e: The major complication of renal biopsy is bleeding. Infection is an extremely rare complication of percutaneous renal biopsy, providing sterile techniques are used and bowel perforation does not occur. However, the questionnaire included in the Kidney Biopsy Guidebook 2020 in Japan reported that antibiotic prophylaxis was administered to patients undergoing percutaneous renal biopsy at 61% of 170 adult institutions and 57% of 54 pediatric institutions. The objective of this study is to show the non-inferiority of not administering prophylactic antibiotics for percutaneous renal biopsy.\u003c/p\u003e\u003cp\u003e•\u0026nbsp;\u003cstrong\u003eMethods\u003c/strong\u003e: Patients aged ≥15 years who are scheduled to undergo percutaneous renal biopsy are eligible for inclusion in the study. Three hundred and sixty-four patients will be recruited at 6 hospitals. The patients will be randomly assigned at a 1:1 ratio to receive either a single dose of intravenous cefazolin (1 g) or no prophylactic antibiotics. The primary outcome is the number of patients that exhibit positive urine cultures (\u0026gt;10\u003csup\u003e5\u003c/sup\u003e colony-forming units/ml) 3 or 4 days after the renal biopsy, at which point the patients are diagnosed with pyelonephritis until 3 or 4 days after the renal biopsy. The secondary outcomes are the number of patients who are diagnosed with pyelonephritis within 30 days after the renal biopsy, the number of patients who are diagnosed with puncture site infections within 30 days after the renal biopsy, the number of patients who are diagnosed with an infection other than pyelonephritis or a puncture site infection within 30 days after the renal biopsy, and the number of patients who experience cefazolin-induced side effects.\u003c/p\u003e\u003cp\u003e•\u0026nbsp;\u003cstrong\u003eDiscussion\u003c/strong\u003e: This randomized controlled trial aims to show the non-inferiority of not administering prophylactic antibiotics for percutaneous renal biopsy. If this study shows that antibiotic prophylaxis is not needed, it would help to ensure patient safety and prevent the development of antibiotic-resistant bacteria.\u003c/p\u003e\u003cp\u003e•\u0026nbsp;\u003cstrong\u003eTrial registration\u003c/strong\u003e:\u0026nbsp;UMIN000042378 [UMIN Clinical Trials Registry (UMIN-CTR)] \u003ca href=\"http://www.umin.ac.jp/ctr\" rel=\"noopener noreferrer\" target=\"_blank\"\u003ehttp://www.umin.ac.jp/ctr\u003c/a\u003e [Registered on 7/Nov/2020]\u003c/p\u003e","manuscriptTitle":"Antibiotic Prophylaxis for Percutaneous Renal Biopsy: Study Protocol for a Prospective Randomized Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2022-03-16 21:31:18","doi":"10.21203/rs.3.rs-1182710/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2022-06-26T22:08:59+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2022-06-20T23:50:00+00:00","index":0,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2022-03-15T09:03:57+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2022-03-14T15:17:19+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2022-03-05T06:33:50+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2021-12-17T23:51:22+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"e15ad4a3-86fe-48a1-892e-6091738d0df7","owner":[],"postedDate":"March 16th, 2022","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2022-08-02T15:00:47+00:00","versionOfRecord":[],"versionCreatedAt":"2022-03-16 21:31:18","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-1182710","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-1182710","identity":"rs-1182710","version":["v1"]},"buildId":"rHA-KDH7Qsr4HCuvH75dn","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}