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Using Antibiotics to Prevent Infections in Hemodialysis Patients During Catheter Placement

NCT06814223 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-02-07

No results posted yet for this study

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.

Conditions

  • Infection Catheter-Related

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).

Sponsors & Collaborators

  • Western Galilee Hospital-Nahariya

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2027-12-30
Completion
2028-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06814223 on ClinicalTrials.gov