Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life
NCT ID: NCT05689801
Last Updated: 2023-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-12-15
2024-01-15
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patient on conventional hemodialysis then on optimized hemodialysis
Questionnaire "recovery time after a dialysis session".
A very short questionnaire just after the dialysis session
SF-12 questionnaire
Questionnaire about quality of life of the patient
EQ-5D-5L Questionnaire
Questionnaire about quality of life of the patient
Pittman, John et McIntyre questionnaire
Questionnaire about quality of life of the patient under dialysis
Conventional hemodialysis
patient on polyethersulfone membrane dialysis (Revaclear®, Baxter) with HemoControl™ for 12 weeks
Optimized hemodialysis
patient on Medium Cut-Off membrane dialysis (Theranova®, Baxter) with HemoControl™ for 12 weeks.
Interventions
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Questionnaire "recovery time after a dialysis session".
A very short questionnaire just after the dialysis session
SF-12 questionnaire
Questionnaire about quality of life of the patient
EQ-5D-5L Questionnaire
Questionnaire about quality of life of the patient
Pittman, John et McIntyre questionnaire
Questionnaire about quality of life of the patient under dialysis
Conventional hemodialysis
patient on polyethersulfone membrane dialysis (Revaclear®, Baxter) with HemoControl™ for 12 weeks
Optimized hemodialysis
patient on Medium Cut-Off membrane dialysis (Theranova®, Baxter) with HemoControl™ for 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Ramsay Générale de Santé
OTHER
Responsible Party
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Locations
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Hôpital Privé Claude Galien
Quincy-sous-Sénart, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-A01511-42
Identifier Type: -
Identifier Source: org_study_id
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