Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient (EASY)

Last updated: March 11, 2025
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Completed

Phase

N/A

Condition

Hemodialysis

Treatment

Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)

Clinical Study ID

NCT04824885
AOI 2019 ANIORT
2020-A00678-31
  • Ages > 18
  • All Genders

Study Summary

This work aims to study the effect of an acetate-free dialysate on protein-energy wasting syndrome in patients with chronic hemodialysis renal failure, in comparison to a conventional dialysate with acetate. The hypothesis is that a dialysate without acetate would improve patients nutritional status

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Major patient;

  • Man or woman ;

  • Treated with intermittent hemodialysis for chronic renal failure;

  • Affiliated with a social security scheme;

  • Having given a signed agreement after detailed explanation of the protocol on thebasis of the information sheet and likely to comply with it

Exclusion

Exclusion Criteria:

  • Patient with lower limb amputation more proximal than a transmetatarsal amputation (invalidity of the model for estimating body composition by BCM in this situation)

  • Acute event in the 3 months preceding inclusion (infection, surgery).

  • Having a neuromuscular pathology responsible for a motor deficit.

  • Whose life expectancy does not exceed 6 months

  • With a psychiatric pathology or cognitive impairment rendering him unable to giveinformed consent

  • Pregnant women

  • Patient under guardianship, curatorship or legal protection

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)
Phase:
Study Start date:
February 15, 2022
Estimated Completion Date:
March 06, 2025

Study Description

The dialysate usually used at the Clermont Ferrand CHU dialysis center is a dialysate containing acetate After inclusion, patients will be randomly divided into two groups. Patients in group 1 will first be treated with the acetate-free dialysate (A-D) for 6 months and then the acetate-containing dialysate (A + D) for 6 months. Group 2 patients will continue on the usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months. Patients will be blinded from study treatment.

Patients will be followed for 1 year.

A the beginning then every 3 months will be carried out:

  • A measurement of body composition by multi-frequency bioimpedancemetry

  • A measurement of the gripping force by a dynamometer (hand grip force )

  • A 4-meter walk test

  • A SARC-F Sarcopenia Assessment Questionnaire A blood test for the usual biological analyzes carried out as part of the recommendations for monitoring patients on hemodialysis will be carried out every month.

An additional blood sample (5.5 mL) for quantification of the levels of expression of potential blood biomarkers of muscle condition will be taken initially, at 6 months and at 12 months (i.e. 16.5 mL more compared to current practice). ).

Connect with a study center

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, 63000
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.