Skip to main content
OpenTrials
Completed

NCT Number: NCT04824885

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

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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). ).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 the basis of the information sheet and likely to comply with it

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 give informed consent
  • Pregnant women
  • Patient under guardianship, curatorship or legal protection

Treatment and study plan

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

Device

usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months

Primary outcomes

  1. prealbumin

    Time frame: change at 6 months from the start of Acetate free or acetate containing dialysate

    biochemical measurement

Secondary outcomes

  1. Muscle mass

    Time frame: change at 6 months from the start of acetate free or acetate containing dialysate

    Lean Tissue Index or LTI from the spectral analysis of body bioimpedance according to the model of Chamney et al, creatine index according Desmeules et al

  2. Muscle performance

    Time frame: change at 6 months from the start of acetate free or acetate containing dialysate

    meter walk test

  3. Muscle performance with hand grip test

    Time frame: change at 6 months from the start of acetate free or acetate containing dialysate

    hand grip test

  4. SARC-F

    Time frame: change at 6 months from the start of acetate free or acetate containing dialysate

    Result of SARC-F survey

  5. muscle biomarkers

    Time frame: Month 6

    blood RNA

  6. muscle biomarkers

    Time frame: Year 1

    blood RNA

  7. mortality

    Time frame: Year 1

    Time to death

  8. morbidity

    Time frame: Year 1

    Time to cardiovascular events

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • INRAE

Registry information

Official study title

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

Acronym: EASY

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2021
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.