Using a special solution to prevent infections in dialysis catheters
Evaluation of the Efficacy of an inTerdialytic "Ethanol 40% v/v - enoxapaRin 1000 U/mL" Lock solutioN to Prevent Tunnelled Catheter Infections in Chronic Hemodialysis Patients: a mulTi-centre, Randomized, Single Blind, Parallel Group studY (ETERNITY)
PHASE3 · University Hospital, Clermont-Ferrand · NCT03083184
This study is testing a new solution made of ethanol and heparin to see if it can help prevent infections in dialysis catheters for people on chronic hemodialysis.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand (other) |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT03083184 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a combined solution of ethanol and low molecular weight heparin in preventing infections related to tunnelled dialysis catheters in chronic hemodialysis patients. The research focuses on reducing catheter-related infections, which are common complications in this patient population and can lead to increased healthcare costs and mortality. By targeting biofilm formation, the study aims to provide a safer alternative to traditional antibiotic lock solutions, which carry risks of resistance. Participants will receive the new lock solution during their hemodialysis sessions to assess its efficacy over time.
Who should consider this trial
Good fit: Ideal candidates are chronic hemodialysis patients with end-stage renal disease who have a functional tunnelled catheter.
Not a fit: Patients who do not have a tunnelled catheter or are not undergoing chronic hemodialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of catheter-related infections in hemodialysis patients, improving their overall health outcomes.
How similar studies have performed: Previous studies have shown promise in using antiseptic solutions to prevent catheter infections, but this specific combination of ethanol and low molecular weight heparin is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * end-stage renal disease * chronic hemodialysis/hemodiafiltration at least three times a week * functional TC inserted for at least two weeks * Social security cover * Written informed consent Exclusion Criteria: \-
Where this trial is running
Clermont-Ferrand
- CHU Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
Study contacts
- Principal investigator: Julien ANIORT — University Hospital, Clermont-Ferrand
- Study coordinator: Patrick LACARIN
- Email: placarin@chu-clermontferrand.fr
- Phone: 04 73 75 10 81
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.
Conditions: Tunnelled Hemodialysis Catheter Infection, Hemodialysis, hemodiafiltration, tunnelled dialysis catheter, interdialytic lock solution, preventing tunnelled catheter infection