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

Not Applicable

• Conditions: Arteriovenous Fistula; Nurse's Role; Cannulation; Hemolysis
• Interventions: Procedure: assisted home hemodialysis patients

• Registration Number: NCT03633435
• Lead Sponsor: University Hospital, Caen

Brief Summary

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

* 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.

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-16
• Study Start: 2019-03-21
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26
• Primary Completion: 2021-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
assisted home hemodialysis patients	assisted home hemodialysis patients	all patients starting assisted home hemodialysis during the study period

Primary Outcome Measures

Name	Time	Method
failure of assisted- HDD	12months	definitive cessation of HHD with transfer to an other dialysis modality.

Trial Locations

Locations (1)

caen University hospital; 🇫🇷 Caen, France