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.
Hemodialysis patients scheduled for new tunneled catheter placement or replacement of an existing tunneled catheter.
Atrial fibrillation
Heart failure
Femoral tunneled catheter
• Hemodialysis patients unable to provide informed consent and requiring a legal guardian.
Patients undergoing prolonged antibiotic therapy prior to tunneled catheter insertion.
Parallel
• Cefamezine (2 grams) and gentamicin (80 mg) administered intravenously. • Patients with penicillin allergies, a history of methicillin-resistant Staphylococcus aureus (MRSA) infection, or known MRSA
DrugPatients with an elevated risk of infection will be randomly assigned to two groups using stratification for new catheter placement versus catheter replacement. Fifty percent of the high-risk patients will receive prophylactic antibiotics targeting gram-positive and gram-negative bacteria. The antibiotic regimen will include: * Cefamezine (2 grams) and gentamicin (80 mg) administered intravenously. * Patients with penicillin allergies, a history of methicillin-resistant Staphylococcus aureus (MRSA) infection, or known MRSA colonization will receive vancomycin (2 grams).
Early catheter-related infection, defined as an infection occurring within 45 days of tunneled catheter insertion.
• Early catheter-related infection, defined as an infection occurring within 45 days of tunneled catheter insertion. (present/absent): These data will be collected from the patient's medical record based on clinical documentation of infection, including positive blood cultures.
Metastatic infection
•Metastatic infection: endocarditis, endovascular infection and osteomyelitis. Present/absent: These data will be collected from the patient's medical record based on clinical documentation of these complications.
Major adverse cardiovascular events (MACE):
Acute myocardial infarction (AMI), stroke, heart failure and cardiovascular death (yes/no) These data will be collected from the patient's medical record based on clinical documentation of these complications..
Mortality
All cause mortality- yes/no. This endpoint will be collected from the patient's medical record.
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