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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05689801
Acronym
EHDXTRQV
Enrollment
20
Registered
2023-01-19
Start date
2022-12-15
Completion date
2024-01-15
Last updated
2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Terminal Renal Insufficiency

Keywords

terminal renal insufficiency

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®.

Interventions

Questionnaire about quality of life of the patient

OTHERPittman, John et McIntyre questionnaire

Questionnaire about quality of life of the patient under dialysis

OTHERQuestionnaire recovery time after a dialysis session.

A very short questionnaire just after the dialysis session

Questionnaire about quality of life of the patient

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

PROCEDUREOptimized hemodialysis

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

Sponsors

Ramsay Générale de Santé
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Result of the questionnaire recovery time after a dialysis session7 monthsonly one question : how long time recovering after a dialysis session (hours)

Countries

France

Contacts

Primary ContactGuy Rostoker, Dr
rostotom@orange.fr01 69 39 92 00

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026