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

NCT03083184 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Clermont-Ferrand

Phase

Phase 3

Started

2018-02-09

Last updated

2023-12-08

Condition(s) studied

Tunnelled Hemodialysis Catheter Infection

Investigational drug(s) / intervention(s)

Ethanol →enoxaparin →

Ethanol: An ethanol 40 % v/v - enoxaparin 1000 U/mL (Ethenox) interdialytic lock solution

enoxaparin: An ethanol 40 % v/v - enoxaparin 1000 U/mL (Ethenox) interdialytic lock solution

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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: \-

Primary outcome measure(s)

Time to first TC infection (TCI) — at 1 year
TCI is a composite endpoint defined by the occurrence of at least one of the three following events: Definitive TC-related bloodstream infection (definitive TCBSI) or Probable TC-related bloodstream infection (probable TCBSI) or TC exit-site infection (ESI). TCI diagnosis and its type (definitive or probable TCBSI or ESI) will be assessed by an endpoint adjudication committee (EAC) according to predefined criteria

Trial sites (1)

Facility	City	Region	Status
CHU Clermont-Ferrand	Clermont-Ferrand	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03083184 on ClinicalTrials.gov ↗ ← All trials in France