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

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Hemodialysis; End Stage Renal Disease

Treatments: Device: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)

Study type: Interventional

Funder types: Other

Identifiers

NCT04824885

AOI 2019 ANIORT

2020-A00678-31 (Other Identifier)

Details and patient eligibility

About

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

Full 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). ).

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Acetate free then acetate containing dialysate

Experimental group

Description:

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.

Treatment:

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

Acetate containing dialysate then acetate free dialysate

Experimental group

Description:

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.

Treatment:

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