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

Study Overview
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Brief Summary
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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®.

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

Conditions
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Terminal Renal Insufficiency

Intervention / Treatment
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* Other: Questionnaire recovery time after a dialysis session.
* Other: SF-12 questionnaire
* Other: EQ-5D-5L Questionnaire
* Other: Pittman, John et McIntyre questionnaire
* Procedure: Conventional hemodialysis
* Procedure: Optimized hemodialysis


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient on conventional hemodialysis then on optimized hemodialysis<br> | Other: Questionnaire recovery time after a dialysis session.<br>* A very short questionnaire just after the dialysis session<br>Other: SF-12 questionnaire<br>* Questionnaire about quality of life of the patient<br>Other: EQ-5D-5L Questionnaire<br>* Questionnaire about quality of life of the patient<br>Other: Pittman, John et McIntyre questionnaire<br>* Questionnaire about quality of life of the patient under dialysis<br>Procedure: Conventional hemodialysis<br>* patient on polyethersulfone membrane dialysis (Revaclear®, Baxter) with HemoControl™ for 12 weeks<br>Procedure: Optimized hemodialysis<br>* patient on Medium Cut-Off membrane dialysis (Theranova®, Baxter) with HemoControl™ for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Result of the questionnaire recovery time after a dialysis session | only one question : how long time recovering after a dialysis session (hours) | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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terminal renal insufficiency