NCT03083184 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
| NCT ID | NCT03083184 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Tunnelled Hemodialysis Catheter Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2018-02-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2018-02-09 with a primary completion date of 2026-12.
⚠ 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 purpose of this study is to assessed the efficacy of a combined solution of ethanol (4%) and low molecular weight heparins LMWH in preventing tunnelled dialysis catheter infection in chronic hemodialysis patients
Eligibility 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: \-
Contact & Investigator
Julien ANIORT
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT03083184 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tunnelled Hemodialysis Catheter Infection. 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 NCT03083184 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT03083184 currently recruiting?
Yes, NCT03083184 is actively recruiting participants. Contact the research team at placarin@chu-clermontferrand.fr for enrollment information.
Where is the NCT03083184 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT03083184 clinical trial?
NCT03083184 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Julien ANIORT at University Hospital, Clermont-Ferrand. The trial plans to enroll 400 participants.