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

Study Overview
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Brief Summary
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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

Detailed Description
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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). ).

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

Conditions
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End Stage Renal Disease, Hemodialysis

Intervention / Treatment
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* Device: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetate free then acetate containing dialysate<br>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)<br>* usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months<br>|
| Experimental: Acetate containing dialysate then acetate free dialysate<br>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)<br>* usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetate free dialysate, hemodialysis