Preventive Antibiotic Treatment Before Insertion or Exchange of Tunneled Cuffed Catheters in Hemodialysis Patients to Prevent Early Catheter-Related Infections

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

• Prior diagnosis of at least one of the following conditions:

‣ Atrial fibrillation

⁃ Heart failure

⁃ Femoral tunneled catheter

∙ Patients who have signed informed consent to participate in the study.

Locations
Other Locations
Israel
Galilee Medical Center
RECRUITING
Nahariya
Time Frame
Start Date: 2024-10-28
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 200
Treatments
Active_comparator: PROPHYLACTIC ANTIBIOTIC
Patients 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).
No_intervention: No
No prophylactic antibiotic before catheter insertion
Sponsors
Leads: Western Galilee Hospital-Nahariya

This content was sourced from clinicaltrials.gov