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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-12-08

No results posted yet for this 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

Conditions

  • Tunnelled Hemodialysis Catheter Infection

Interventions

DRUG

Ethanol

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

DRUG

enoxaparin

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV
  • CH du Puy en Velay, Hôpital Emile Roux

    collaborator UNKNOWN
  • University Hospital, Toulouse

    collaborator OTHER
  • Centre hospitalier de Chambéry

    collaborator UNKNOWN
  • Calydial

    collaborator OTHER
  • Hôpital Edouard Herriot

    collaborator OTHER
  • Nouvel Hôpital Civil, 1 place de l'Hôpital 67091 Strasbourg cedex

    collaborator UNKNOWN
  • Hôpital Lapeyronie

    collaborator UNKNOWN
  • Centre de dialyse d'Alès

    collaborator UNKNOWN
  • University Hospital of Saint-Etienne

    collaborator OTHER
  • Centre hospitalier de Perpignan

    collaborator OTHER
  • Centre de néphrologie Polyclinique Médipôle Saint-Roch, Rue Ambroise Croizat

    collaborator UNKNOWN
  • CHU Hôpital Maison Blanche, 45 Rue Cognacq-Jay 51092 REIMS Cedex

    collaborator UNKNOWN
  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Julien ANIORT · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083184 on ClinicalTrials.gov