NCT06814223 Using Antibiotics to Prevent Infections in Hemodialysis Patients During Catheter Placement
| NCT ID | NCT06814223 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Western Galilee Hospital-Nahariya |
| Condition | Infection Catheter-Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2024-10-28 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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: 1. Atrial fibrillation 2. Heart failure 3. Femoral tunneled catheter * Patients who have signed informed consent to participate in the study. Exclusion Criteria: * • Hemodialysis patients unable to provide informed consent and requiring a legal guardian. * Patients undergoing prolonged antibiotic therapy prior to tunneled catheter insertion.
Frequently Asked Questions
Who can join the NCT06814223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infection Catheter-Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06814223 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06814223 currently recruiting?
Yes, NCT06814223 is actively recruiting participants. Visit ClinicalTrials.gov or contact Western Galilee Hospital-Nahariya to inquire about joining.
Where is the NCT06814223 trial being conducted?
This trial is being conducted at Nahariya, Israel.
Who is sponsoring the NCT06814223 clinical trial?
NCT06814223 is sponsored by Western Galilee Hospital-Nahariya. The trial plans to enroll 200 participants.