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

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ClinicalTrials.gov Identifier: NCT03633435
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : February 26, 2021
Sponsor:
Collaborator:
NxStage Medical
Information provided by (Responsible Party):
University Hospital, Caen

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : March 21, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Fistulas

Arms and Interventions
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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
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Primary Outcome Measures :
  1. failure of assisted- HDD [ Time Frame: 12months ]
    definitive cessation of HHD with transfer to an other dialysis modality.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633435


Locations
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France
caen University hospital Recruiting
Caen, France, 14000
Contact: Clémence Béchade, PhD    +33231272575    bechade-c@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen
NxStage Medical
More Information
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03633435    
Other Study ID Numbers: 2018-A00992-53
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: February 26, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Hemolysis
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
 Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathologic Processes