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

Sponsor

University Hospital, Caen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03633435

Collaborator

NxStage Medical (Other)

Enrollment

Location

Arm

43.4

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemolysis Cannulation Arteriovenous Fistula Nurse's Role	Procedure: assisted home hemodialysis patients	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 21, 2019

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: assisted home hemodialysis patients all patients starting assisted home hemodialysis during the study period	Procedure: 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

Arm

Intervention/Treatment

Experimental: assisted home hemodialysis patients

all patients starting assisted home hemodialysis during the study period

Procedure: 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

Outcome Measures

Primary Outcome Measures

failure of assisted- HDD [12months]
definitive cessation of HHD with transfer to an other dialysis modality.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	caen University hospital	Caen		France	14000

Sponsors and Collaborators

University Hospital, Caen
NxStage Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT03633435

Other Study ID Numbers:

2018-A00992-53

First Posted:

Aug 16, 2018

Last Update Posted:

Feb 26, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Arteriovenous Fistula

Fistula

Hemolysis

Study Results

No Results Posted as of Feb 26, 2021