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Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life (EHDXTRQV)

Primary Purpose

Terminal Renal Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire "recovery time after a dialysis session".
SF-12 questionnaire
EQ-5D-5L Questionnaire
Pittman, John et McIntyre questionnaire
Conventional hemodialysis
Optimized hemodialysis
Sponsored by
Ramsay Générale de Santé
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Terminal Renal Insufficiency focused on measuring terminal renal insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient, male or female (using contraceptives, if of childbearing age), over 18 years of age Patient on conventional hemodialysis with synthetic membrane for at least 3 months Patient with a recovery time after the dialysis session ≥ 4 hours Informed patient who has signed a written consent to participate in the study Affiliated patient or beneficiary of a social security scheme Exclusion Criteria: Patient whose seniority of dialysis is less than 3 months Pregnant woman Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision Patient with severe cognitive impairment Medically unstable or frail patient Patient who did not sign an informed consent form accepting this research (refusal of consent or absence of signature).

Sites / Locations

  • Hôpital Privé Claude GalienRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient on conventional hemodialysis then on optimized hemodialysis

Arm Description

Outcomes

Primary Outcome Measures

Result of the questionnaire "recovery time after a dialysis session"
only one question : how long time recovering after a dialysis session (hours)

Secondary Outcome Measures

Full Information

First Posted
December 22, 2022
Last Updated
January 10, 2023
Sponsor
Ramsay Générale de Santé
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1. Study Identification

Unique Protocol Identification Number
NCT05689801
Brief Title
Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life
Acronym
EHDXTRQV
Official Title
Pilot Study: Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In this study, the effect of optimizing the dialytic technique using simple questionnaires carried out in clinical routine will be described. More specifically, the conventional dialysis technique will be combined with biofeedback software called HemoControl™. The recovery time and quality of life of patients who will use a polyethersulfone membrane (Revaclear®) and a Medium Cut-Off (MCO) membrane (Theranova®) will be observed. The main objective is to describe the evolution of recovery time after a dialysis session in conventional hemodialysis (HD) on Revaclear® membrane and in so-called optimized hemodialysis (HDx) on MCO membrane, Theranova®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Terminal Renal Insufficiency
Keywords
terminal renal insufficiency

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient on conventional hemodialysis then on optimized hemodialysis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Questionnaire "recovery time after a dialysis session".
Intervention Description
A very short questionnaire just after the dialysis session
Intervention Type
Other
Intervention Name(s)
SF-12 questionnaire
Intervention Description
Questionnaire about quality of life of the patient
Intervention Type
Other
Intervention Name(s)
EQ-5D-5L Questionnaire
Intervention Description
Questionnaire about quality of life of the patient
Intervention Type
Other
Intervention Name(s)
Pittman, John et McIntyre questionnaire
Intervention Description
Questionnaire about quality of life of the patient under dialysis
Intervention Type
Procedure
Intervention Name(s)
Conventional hemodialysis
Intervention Description
patient on polyethersulfone membrane dialysis (Revaclear®, Baxter) with HemoControl™ for 12 weeks
Intervention Type
Procedure
Intervention Name(s)
Optimized hemodialysis
Intervention Description
patient on Medium Cut-Off membrane dialysis (Theranova®, Baxter) with HemoControl™ for 12 weeks.
Primary Outcome Measure Information:
Title
Result of the questionnaire "recovery time after a dialysis session"
Description
only one question : how long time recovering after a dialysis session (hours)
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient, male or female (using contraceptives, if of childbearing age), over 18 years of age Patient on conventional hemodialysis with synthetic membrane for at least 3 months Patient with a recovery time after the dialysis session ≥ 4 hours Informed patient who has signed a written consent to participate in the study Affiliated patient or beneficiary of a social security scheme Exclusion Criteria: Patient whose seniority of dialysis is less than 3 months Pregnant woman Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision Patient with severe cognitive impairment Medically unstable or frail patient Patient who did not sign an informed consent form accepting this research (refusal of consent or absence of signature).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guy Rostoker, Dr
Phone
01 69 39 92 00
Email
rostotom@orange.fr
Facility Information:
Facility Name
Hôpital Privé Claude Galien
City
Quincy-sous-Sénart
ZIP/Postal Code
91480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy ROSTOKER, Dr
Phone
01 69 39 92 00
Email
rostotom@orange.fr

12. IPD Sharing Statement

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Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life

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