Preventing infections in hemodialysis patients during catheter placement with antibiotics
Preventive Antibiotic Treatment Before Insertion or Exchange of Tunneled Cuffed Catheters in Hemodialysis Patients to Prevent Early Catheter-Related Infections
This study tests if giving antibiotics before catheter placement can help prevent infections in hemodialysis patients who are at high risk.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western Galilee Hospital-Nahariya Government |
| Locations | 1 site (Nahariya, Israel) |
| Trial ID | NCT06814223 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of prophylactic antibiotics in reducing early catheter-related infections among hemodialysis patients at high risk. Participants will be randomized into two groups: one receiving antibiotics such as cefamezine and gentamicin, and the other receiving no antibiotics before catheter placement. The study will assess the incidence of infections and secondary complications within 45 days of catheter insertion. The goal is to determine if antibiotic administration can significantly lower infection rates and associated morbidity and mortality.
Who should consider this trial
Good fit: Ideal candidates include hemodialysis patients scheduled for new tunneled catheter placement or replacement who have a history of atrial fibrillation, heart failure, or require a femoral catheter.
Not a fit: Patients unable to provide informed consent or those undergoing prolonged antibiotic therapy prior to catheter insertion may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of infections and improve outcomes for hemodialysis patients.
How similar studies have performed: Other studies have shown promising results with prophylactic antibiotics in similar high-risk populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nahariya, Israel
- Galilee Medical Center — Nahariya, Israel, Israel (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.