Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation

NCT ID: NCT03633435

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-21

Study Completion Date

2022-11-30

Brief Summary

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Home HD (HHD) is associated with better outcome in end-stage renal disease patients compared to in-center HD, in particular in terms of quality of life. However fear of AVF cannulation is a known barrier for patient's choice and adoption of a HHD program. Providing nurse assistance for the cannulation can help developing HHD programs. The aim of this study is to evaluate the feasibility of assisted home hemodialysis, with the intervention of a nurse at home for arterio-venous fistula cannulation.

Detailed Description

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* Monocentric prospective interventional study.
* Intervention is assisted HHD, defined as: rope-ladder cannulation at the patient's home provided by a trained private nurse at each dialysis session, and connection to the Nxstage System One
* pilot study, with main objective defined as feasibility of the investigator's assisted HHD program. Pilot study usually concerns a small population, allowing us to develop thereafter a bigger study if the results are encouraging.
* primary end-point criteria defined as definitive cessation of HHD with transfer to an other dialysis modality.

Conditions

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Hemolysis Cannulation Arteriovenous Fistula Nurse's Role

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All incident and prevalent dialysis patients of our unit will get information on that assisted HHD program and will be able to choose this technique
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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assisted home hemodialysis patients

all patients starting assisted home hemodialysis during the study period

Group Type EXPERIMENTAL

assisted home hemodialysis patients

Intervention Type PROCEDURE

Arteriovenous fistula cannulation at the patient's home provided by a trained private nurse at each dialysis session with the rope-ladder technique, and connection to the Nxstage System One

Interventions

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assisted home hemodialysis patients

Arteriovenous fistula cannulation at the patient's home provided by a trained private nurse at each dialysis session with the rope-ladder technique, and connection to the Nxstage System One

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* The patient must be aged more than 18, able to read and write, and have a person with him at home during HD session, according to the french law.

Exclusion Criteria

* medical contra-indication for HHD
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NxStage Medical

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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caen University hospital

Caen, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Clémence Béchade, PhD

Role: primary

+33231272575

Other Identifiers

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2018-A00992-53

Identifier Type: -

Identifier Source: org_study_id

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