NCT03083184

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
19mo left

Started Feb 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Feb 2018Dec 2027

First Submitted

Initial submission to the registry

March 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

February 9, 2018

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 8, 2023

Status Verified

May 1, 2023

Enrollment Period

8.8 years

First QC Date

March 7, 2017

Last Update Submit

December 7, 2023

Conditions

Tunnelled Hemodialysis Catheter Infection

Keywords

Hemodialysishemodiafiltrationtunnelled dialysis catheterinterdialytic lock solutionpreventing tunnelled catheter infection

Outcome Measures

Primary Outcomes (1)

  • Time to first TC infection (TCI)

    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

    at 1 year

Secondary Outcomes (17)

  • Time to first definitive or probable TCBSI

    at 1 year

  • Time to first ESI

    at 1 year

  • Incidence rate of definitive or probable TCBSI

    at 1 year

  • Incidence rate of ESI

    at 1 year

  • prevalence of colonizations of removed TCs for each TC removed

    at 1 year

  • +12 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Enrolled patients will be randomly assigned in a 1:1 ratio either to the intervention group (Ethenox) or to the control group (reference solution: UFH 5000 U/mL or citrate 4% w/v depending on which solution is generally used).

Drug: Ethanol

control group

OTHER

Enrolled patients will be randomly assigned in a 1:1 ratio either to the intervention group (Ethenox) or to the control group (reference solution: UFH 5000 U/mL or citrate 4% w/v depending on which solution is generally used).

Drug: enoxaparin

Interventions

EthanolDRUG

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

Intervention group
enoxaparinDRUG

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

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

  • Aniort J, Piraud A, Adda M, Perreira B, Bouiller M, Fourcade J, Guerraoui A, Kalbacher E, Krumel T, Moragues HL, Thibaudin D, Vela CG, Vernin G, Weclawiak H, Bernard L, Heng AE, Souweine B. 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 Nephrol. 2019 Apr 30;20(1):149. doi: 10.1186/s12882-019-1338-6.

    PMID: 31039759DERIVED

MeSH Terms

Interventions

EthanolEnoxaparin

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsHeparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Julien ANIORT

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 10 81placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 17, 2017

Study Start

February 9, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

December 8, 2023

Record last verified: 2023-05

Locations

FR(1)