Using Antibiotics to Prevent Infections in Hemodialysis Patients During Catheter Placement

Summary

The goal of this clinical trial is to determine if prophylactic antibiotic treatment can reduce the incidence of early catheter-related infections in hemodialysis patients at high risk, including those with femoral catheter placement, atrial fibrillation, or heart failure. The main questions it aims to answer are: 1. Will prophylactic antibiotic administration reduce catheter-related infections by 50% within 45 days of catheter insertion? 2. Will this intervention decrease the rate of secondary complications such as metastatic infections, cardiovascular morbidity, and mortality? Researchers will compare patients receiving prophylactic antibiotics (e.g., cefamezine and gentamicin, or vancomycin for high-risk individuals) to those not receiving antibiotics, to assess the difference in infection rates and associated complications. Participants : * Be randomized into two groups: one receiving prophylactic antibiotics and one without antibiotics before catheter placement or replacement. * Undergo follow-up for 45 days to monitor for catheter-related infections and secondary complications. This study will provide critical data to evaluate whether targeted prophylactic antibiotic treatment should become standard practice for high-risk hemodialysis patients.

Timeline

Start

2024-10-28

Primary completion

2027-12-30

Completion

2028-06-30

Publications

• Background 1. https://usrds-adr.niddk.nih.gov/2023/end-stage-renal-disease/4-vascular-access, 2021 2. Lassalle M, Monnet E, Ayav C, Hogan J, Moranne O, Couchoud C, et al. 2017 annual report digest of the renal epidemiology information network (REIN) registry. Transpl. Int. 2019;32(9):892-902. doi: 10.1111/tri.13466. 3. Arhuidese IJ, Cooper MA, Rizwan M, Nejim B, Malas MB. Vascular access for hemodialysis in the elderly. J. Vasc. Surg. 2019;69(2):517-525. doi: 10.1016/j.jvs.2018.05.219. 4. Ravani P, Palmer SC, Oliver MJ, Quinn RR, MacRae JM, Tai DJ, et al. Associations between hemodialysis access type and clinical outcomes: A systematic review. J. Am. Soc. Nephrol. 2013;24(3):465-473. doi: 10.1681/ASN.2012070643. 5. Aslam S, Vaida F, Ritter M, Ravindra L. Systematic review and meta-analysis on management of hemodialysis catheter-related bacteremia. J. Am. Soc. Nephrol. 2014;25(12):2927-2941. doi: 10.1681/ASN.2013091009. 6. Tokars JI, Miller ER, Stein G. New national surveillance system for hemodialysis associated infections: initial results. Am J Infect Control. 2002;30(5):288-295. 7. Chavers BM, Solid CA, Gilbertson DT, Collins AJ. Infection-related hospitalization rates in pediatric versus adult patients with end-stage renal disease in the United States. J Am Soc Nephrol. 2007 Mar;18(3):952-9. 8. Farrington CA, Allon M. Complications of Hemodialysis Catheter Bloodstream Infections: Impact of Infecting Organism. Am J Nephrol. 2019;50(2):126-132. 9. Delistefani, F., Wallbach, M., Müller, G.A. et al. Risk factors for catheter-related infections in patients receiving permanent dialysis catheter. BMC Nephrol 20, 199 (2019). 10. Huajie Guo , Ling Zhang ,Hua He , Lili Wang. Risk factors for catheter-associated bloodstream infection in hemodialysis patients: A meta-analysis. Published: March 27, 2024. Crossref DOI link: https://doi.org/10.1371/journal.pone.0299715 11. Pyry N. Sipilä, Joni V. Lindbohm, G. David Batty, Nelli Heikkilä, Jussi Vahtera, Sakari Suominen, Ari Väänänen

Drugs

Indications