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

End Stage Renal Disease Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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). ). ;

Related Conditions & MeSH terms

• Cachexia
• End Stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic

• NCT number: NCT04824885
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci@chu-clermontferrand.fr
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Completion date: February 2024