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

Ramsay Générale de Santé

Status: Enrolling

Conditions: Terminal Renal Insufficiency

Treatments: Procedure: Optimized hemodialysis; Other: SF-12 questionnaire; Other: EQ-5D-5L Questionnaire; Other: Pittman, John et McIntyre questionnaire; Procedure: Conventional hemodialysis; Other: Questionnaire "recovery time after a dialysis session".

Study type: Interventional

Funder types: Other

Identifiers

NCT05689801

2022-A01511-42

Details and patient eligibility

About

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®.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Patient on conventional hemodialysis then on optimized hemodialysis

Experimental group

Treatment:

Other: Pittman, John et McIntyre questionnaire

Procedure: Conventional hemodialysis

Other: EQ-5D-5L Questionnaire

Other: Questionnaire "recovery time after a dialysis session".

Procedure: Optimized hemodialysis

Other: SF-12 questionnaire