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

Terminal Renal Insufficiency Clinical Trial

— EHDXTRQV  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05689801
• Other study ID #: 2022-A01511-42
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: January 2023
• Source: Ramsay Générale de Santé
• Contact: Guy Rostoker, Dr
• Phone: 01 69 39 92 00
• Email: rostotom[@]orange.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 15, 2024
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Renal Insufficiency
• Terminal Renal Insufficiency

Intervention

Other:
• 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

Procedure:
• 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.

Locations

Country	Name	City	State
France	Hôpital Privé Claude Galien	Quincy-sous-Sénart

Sponsors (1)

Lead Sponsor	Collaborator
Ramsay Générale de Santé

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Result of the questionnaire "recovery time after a dialysis session"	only one question : how long time recovering after a dialysis session (hours)	7 months