NCT05689801

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®.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

December 22, 2022

Last Update Submit

January 10, 2023

Conditions

Terminal Renal Insufficiency

Keywords

terminal renal insufficiency

Outcome Measures

Primary Outcomes (1)

  • Result of the questionnaire "recovery time after a dialysis session"

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

    7 months

Study Arms (1)

Patient on conventional hemodialysis then on optimized hemodialysis

EXPERIMENTAL
Other: Questionnaire "recovery time after a dialysis session".Other: SF-12 questionnaireOther: EQ-5D-5L QuestionnaireOther: Pittman, John et McIntyre questionnaireProcedure: Conventional hemodialysisProcedure: Optimized hemodialysis

Interventions

Questionnaire "recovery time after a dialysis session".OTHER

A very short questionnaire just after the dialysis session

Patient on conventional hemodialysis then on optimized hemodialysis
SF-12 questionnaireOTHER

Questionnaire about quality of life of the patient

Patient on conventional hemodialysis then on optimized hemodialysis
EQ-5D-5L QuestionnaireOTHER

Questionnaire about quality of life of the patient

Patient on conventional hemodialysis then on optimized hemodialysis
Pittman, John et McIntyre questionnaireOTHER

Questionnaire about quality of life of the patient under dialysis

Patient on conventional hemodialysis then on optimized hemodialysis
Conventional hemodialysisPROCEDURE

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

Patient on conventional hemodialysis then on optimized hemodialysis
Optimized hemodialysisPROCEDURE

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

Patient on conventional hemodialysis then on optimized hemodialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

RECRUITING

Central Study Contacts

Guy Rostoker, Dr

CONTACT

01 69 39 92 00rostotom@orange.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 19, 2023

Study Start

December 15, 2022

Primary Completion

June 15, 2023

Study Completion

January 15, 2024

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations

FR(1)