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Completed

NCT Number: NCT05689801

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

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®.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Questionnaire "recovery time after a dialysis session".

Other

A very short questionnaire just after the dialysis session

SF-12 questionnaire

Other

Questionnaire about quality of life of the patient

EQ-5D-5L questionnaire

Other

Questionnaire about quality of life of the patient

Pittman, John et McIntyre questionnaire

Other

Questionnaire about quality of life of the patient under dialysis

Conventional Hemodialysis

Procedure

patient on polyethersulfone membrane dialysis (Revaclear®, Baxter) with HemoControl™ for 12 weeks

Optimized hemodialysis

Procedure

patient on Medium Cut-Off membrane dialysis (Theranova®, Baxter) with HemoControl™ for 12 weeks.

Primary outcomes

  1. Result of the questionnaire "recovery time after a dialysis session"

    Time frame: 7 months

    only one question : how long time recovering after a dialysis session (hours)

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Acronym: EHDXTRQV

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.