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
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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