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Clinical Trials/NCT03633435
NCT03633435
Unknown
Not Applicable

Feasibility of a Home HD Program Assisted by a Nurse Coming at Home for Arterio-venous Fistula (AVF) Cannulation

University Hospital, Caen1 site in 1 country10 target enrollmentMarch 21, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemolysis
Sponsor
University Hospital, Caen
Enrollment
10
Locations
1
Primary Endpoint
failure of assisted- HDD
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 21, 2019
End Date
November 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

failure of assisted- HDD

Time Frame: 12months

definitive cessation of HHD with transfer to an other dialysis modality.

Study Sites (1)

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