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

Sponsor
Ramsay Générale de Santé (Other)
Overall Status
Recruiting
CT.gov ID
NCT05689801
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
13
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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®.

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pilot Study: Describe the Effect of the Optimized Hemodialysis Technique (HDx) With Medium Cut-Off Membrane on Recovery Time and Quality of Life
Actual Study Start Date :
Dec 15, 2022
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Jan 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient on conventional hemodialysis then on optimized hemodialysis

Other: Questionnaire "recovery time after a dialysis session".
A very short questionnaire just after the dialysis session

Other: SF-12 questionnaire
Questionnaire about quality of life of the patient

Other: EQ-5D-5L Questionnaire
Questionnaire about quality of life of the patient

Other: Pittman, John et McIntyre questionnaire
Questionnaire about quality of life of the patient under dialysis

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

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

Outcome Measures

Primary Outcome Measures

  1. Result of the questionnaire "recovery time after a dialysis session" [7 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Privé Claude Galien Quincy-sous-Sénart France 91480

Sponsors and Collaborators

  • Ramsay Générale de Santé

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ramsay Générale de Santé
ClinicalTrials.gov Identifier:
NCT05689801
Other Study ID Numbers:
  • 2022-A01511-42
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ramsay Générale de Santé
terminal renal insufficiency
Additional relevant MeSH terms:
Renal Insufficiency

Study Results

No Results Posted as of Jan 19, 2023