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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis; End Stage Renal Disease
• Intervention / Treatment: Device: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)

Detailed 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). ).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Julien ANIORT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetate free then acetate containing dialysate; 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.	Device: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device); usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months
Experimental: Acetate containing dialysate then acetate free dialysate; 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.	Device: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device); usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prealbumin	biochemical measurement	change at 6 months from the start of Acetate free or acetate containing dialysate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle mass	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	change at 6 months from the start of acetate free or acetate containing dialysate
Muscle performance	meter walk test	change at 6 months from the start of acetate free or acetate containing dialysate
Muscle performance with hand grip test	hand grip test	change at 6 months from the start of acetate free or acetate containing dialysate
SARC-F	Result of SARC-F survey	change at 6 months from the start of acetate free or acetate containing dialysate
muscle biomarkers	blood RNA	Month 6
muscle biomarkers	blood RNA	Year 1
mortality	Time to death	Year 1
morbidity	Time to cardiovascular events	Year 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: hemodialysis; Acetate free dialysate
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Nutrition Disorders; Body Weight; Body Weight Changes; Renal Insufficiency, Chronic; Emaciation; Weight Loss; Kidney Failure, Chronic; Wasting Syndrome; Cachexia
• Other Study ID Numbers: AOI 2019 ANIORT; 2020-A00678-31 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No