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RECRUITING
NCT06814223
PHASE4

Using Antibiotics to Prevent Infections in Hemodialysis Patients During Catheter Placement

Sponsor: Western Galilee Hospital-Nahariya

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-10-28

Completion Date

2028-06-30

Last Updated

2025-02-07

Healthy Volunteers

No

Interventions

DRUG

• 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

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).

Locations (1)

Galilee Medical Center

Nahariya, Israel, Israel