Using Antibiotics to Prevent Infections in Hemodialysis Patients During Catheter Placement

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern Galilee Hospital-Nahariya

About this trial

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.

Eligibility criteria

Qualifiers

Hemodialysis patients scheduled for new tunneled catheter placement or replacement of an existing tunneled catheter.

Atrial fibrillation

Heart failure

Femoral tunneled catheter

Disqualifiers

• Hemodialysis patients unable to provide informed consent and requiring a legal guardian.

Patients undergoing prolonged antibiotic therapy prior to tunneled catheter insertion.

Trial design

Treatments tested in this trial

  • • 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

Treatment groups

200 Participants
are divided into 2 treatment groups