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

Abstract Background Tunnelled dialysis catheter (TC) infections are a major health complication and are associated with increased antibiotic consumption, hospital stays, health costs and mortality. Experimental data provide evidence that Ethenox, a mixture of enoxaparine 1000 U/mL in 40% v/v ethanol...

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Main Authors: Julien Aniort, Aurélien Piraud, Mireille Adda, Bruno Perreira, Marc Bouiller, Jacques Fourcade, Abdallah Guerraoui, Emilie Kalbacher, Thierry Krumel, Hélène Leray Moragues, Damien Thibaudin, Carlos Gustavo Vela, Guillaume Vernin, Hugo Weclawiak, Lise Bernard, Anne Elisabeth Heng, Bertrand Souweine
Format: Article
Language:English
Published: BMC 2019-04-01
Series:BMC Nephrology
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12882-019-1338-6
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spelling doaj-29570724221a495a88a453486aa55ea62020-11-25T02:54:23ZengBMCBMC Nephrology1471-23692019-04-0120111010.1186/s12882-019-1338-6Evaluation 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 studyJulien Aniort0Aurélien Piraud1Mireille Adda2Bruno Perreira3Marc Bouiller4Jacques Fourcade5Abdallah Guerraoui6Emilie Kalbacher7Thierry Krumel8Hélène Leray Moragues9Damien Thibaudin10Carlos Gustavo Vela11Guillaume Vernin12Hugo Weclawiak13Lise Bernard14Anne Elisabeth Heng15Bertrand Souweine16Nephrology, Dialysis and Transplantation Department, Gabriel Montpied University HospitalNephrology, Dialysis and Transplantation Department, Gabriel Montpied University HospitalMedical Intensive Care Unit, Gabriel Montpied University HospitalBiostatistics Unit (DRCI), University Hospital of Clermont-FerrandNephrology and Dialysis Department, Emile Roux HospitalNephrology and Dialysis Department, Metropole-Savoie HospitalCalydial ViennesNephrology and Dialysis Department, Edouard Herriot University HospitalNephrology and Dialysis Department, University HospitalAIDERNephrology and Dialysis Department, University HospitalNephrology and Dialysis Department, HospitalAGDUCNephrology and Dialysis Department, Médipole Saint-Roch ClinicPharmacy department, Gabriel Montpied University HospitalNephrology, Dialysis and Transplantation Department, Gabriel Montpied University HospitalMedical Intensive Care Unit, Gabriel Montpied University HospitalAbstract Background Tunnelled dialysis catheter (TC) infections are a major health complication and are associated with increased antibiotic consumption, hospital stays, health costs and mortality. Experimental data provide evidence that Ethenox, a mixture of enoxaparine 1000 U/mL in 40% v/v ethanol, could be a promising lock solution. The aim of the study is to compare an interdialytic lock solution of Ethenox with reference lock solutions, unfractionated heparin (UFH) or citrate 4% for the prevention of TCI in hemodialysis patients. Method This study will monitor a multicentre, prospective, single blind, randomized, controlled, parallel group trial. The main inclusion criteria are patients > 18 years old with end-stage renal disease, treated with chronic hemodialysis/hemodiafiltration three times a week, with incident or prevalent non-impregnated internal jugular TCs inserted for at least 2 weeks and able to give informed consent. Exclusion criteria are TCI in the previous 4 weeks and anti-infective treatment for TCI in the previous 2 weeks. Patients will be randomized to receive either study treatment Ethenox in the intervention group or reference solutions in the control group, unfractionated heparin (UFH) or citrate 4% w/v according to usual practice. The primary outcome measure will be time to first TCIs assessed by an endpoint adjudication committee blinded to the study arm according to predefined criteria. Patients will receive the study treatment for up to 12 months. Intention-to-treat analysis of the primary endpoint will be performed with a marginal Cox proportional hazard model. Prospective power calculations indicate that the study will have 90% statistical power to detect a clinical significant two-fold increase in median infection-free survival if 200 patients are recruited into each arm over a period of 24 months. Discussion Firm evidence of the efficacy of the Ethenox lock in preventing TCI could be of major clinical benefit for patients. The results of this study will allow the development of new guidelines based on a high level of evidence. Trial registration ClinicalTrials.gov Identifier: NCT03083184, date of registration March 17 2017 and European Clinical Trials Database Identifier: EudraCT 2016-A00180-51), date of registration July 11 2016.http://link.springer.com/article/10.1186/s12882-019-1338-6TunnelledHemodialysisCatheterInfectionEthanolLow molecular weight heparin
collection DOAJ
language English
format Article
sources DOAJ
author Julien Aniort
Aurélien Piraud
Mireille Adda
Bruno Perreira
Marc Bouiller
Jacques Fourcade
Abdallah Guerraoui
Emilie Kalbacher
Thierry Krumel
Hélène Leray Moragues
Damien Thibaudin
Carlos Gustavo Vela
Guillaume Vernin
Hugo Weclawiak
Lise Bernard
Anne Elisabeth Heng
Bertrand Souweine
spellingShingle Julien Aniort
Aurélien Piraud
Mireille Adda
Bruno Perreira
Marc Bouiller
Jacques Fourcade
Abdallah Guerraoui
Emilie Kalbacher
Thierry Krumel
Hélène Leray Moragues
Damien Thibaudin
Carlos Gustavo Vela
Guillaume Vernin
Hugo Weclawiak
Lise Bernard
Anne Elisabeth Heng
Bertrand Souweine
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
BMC Nephrology
Tunnelled
Hemodialysis
Catheter
Infection
Ethanol
Low molecular weight heparin
author_facet Julien Aniort
Aurélien Piraud
Mireille Adda
Bruno Perreira
Marc Bouiller
Jacques Fourcade
Abdallah Guerraoui
Emilie Kalbacher
Thierry Krumel
Hélène Leray Moragues
Damien Thibaudin
Carlos Gustavo Vela
Guillaume Vernin
Hugo Weclawiak
Lise Bernard
Anne Elisabeth Heng
Bertrand Souweine
author_sort Julien Aniort
title 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
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
publisher BMC
series BMC Nephrology
issn 1471-2369
publishDate 2019-04-01
description Abstract Background Tunnelled dialysis catheter (TC) infections are a major health complication and are associated with increased antibiotic consumption, hospital stays, health costs and mortality. Experimental data provide evidence that Ethenox, a mixture of enoxaparine 1000 U/mL in 40% v/v ethanol, could be a promising lock solution. The aim of the study is to compare an interdialytic lock solution of Ethenox with reference lock solutions, unfractionated heparin (UFH) or citrate 4% for the prevention of TCI in hemodialysis patients. Method This study will monitor a multicentre, prospective, single blind, randomized, controlled, parallel group trial. The main inclusion criteria are patients > 18 years old with end-stage renal disease, treated with chronic hemodialysis/hemodiafiltration three times a week, with incident or prevalent non-impregnated internal jugular TCs inserted for at least 2 weeks and able to give informed consent. Exclusion criteria are TCI in the previous 4 weeks and anti-infective treatment for TCI in the previous 2 weeks. Patients will be randomized to receive either study treatment Ethenox in the intervention group or reference solutions in the control group, unfractionated heparin (UFH) or citrate 4% w/v according to usual practice. The primary outcome measure will be time to first TCIs assessed by an endpoint adjudication committee blinded to the study arm according to predefined criteria. Patients will receive the study treatment for up to 12 months. Intention-to-treat analysis of the primary endpoint will be performed with a marginal Cox proportional hazard model. Prospective power calculations indicate that the study will have 90% statistical power to detect a clinical significant two-fold increase in median infection-free survival if 200 patients are recruited into each arm over a period of 24 months. Discussion Firm evidence of the efficacy of the Ethenox lock in preventing TCI could be of major clinical benefit for patients. The results of this study will allow the development of new guidelines based on a high level of evidence. Trial registration ClinicalTrials.gov Identifier: NCT03083184, date of registration March 17 2017 and European Clinical Trials Database Identifier: EudraCT 2016-A00180-51), date of registration July 11 2016.
topic Tunnelled
Hemodialysis
Catheter
Infection
Ethanol
Low molecular weight heparin
url http://link.springer.com/article/10.1186/s12882-019-1338-6
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