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

Not Applicable

Recruiting

• Conditions: Terminal Renal Insufficiency
• Interventions: 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

• Registration Number: NCT05689801
• Lead Sponsor: Ramsay Générale de Santé

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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Study First Submitted: 2022-12-22
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-10
• Last Update Submitted: 2023-01-10
• Study First Posted: 2023-01-19
• Last Update Posted: 2023-01-19
• Primary Completion: 2023-06-15
• Study Completion: 2024-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient on conventional hemodialysis then on optimized hemodialysis	Pittman, John et McIntyre questionnaire	-
Patient on conventional hemodialysis then on optimized hemodialysis	Optimized hemodialysis	-
Patient on conventional hemodialysis then on optimized hemodialysis	EQ-5D-5L Questionnaire	-
Patient on conventional hemodialysis then on optimized hemodialysis	Questionnaire "recovery time after a dialysis session".	-
Patient on conventional hemodialysis then on optimized hemodialysis	SF-12 questionnaire	-
Patient on conventional hemodialysis then on optimized hemodialysis	Conventional hemodialysis	-

Primary Outcome Measures

Name	Time	Method
Result of the questionnaire "recovery time after a dialysis session"	7 months	only one question : how long time recovering after a dialysis session (hours)

Trial Locations

Locations (1)

Hôpital Privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France