Clinical trial NCT04824885: Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient (EASY)
Official title: Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Hemodialysis
Keywords: Acetate free dialysate
hemodialysis
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: INRAE
First posted: 2021-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

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). ).

Eligibility criteria: 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

Primary outcomes:
measure: prealbumin
timeFrame: change at 6 months from the start of Acetate free or acetate containing dialysate
Secondary outcomes:
measure: Muscle mass
timeFrame: change at 6 months from the start of acetate free or acetate containing dialysate
measure: Muscle performance
timeFrame: change at 6 months from the start of acetate free or acetate containing dialysate
measure: Muscle performance with hand grip test
timeFrame: change at 6 months from the start of acetate free or acetate containing dialysate
measure: SARC-F
timeFrame: change at 6 months from the start of acetate free or acetate containing dialysate
measure: muscle biomarkers
timeFrame: Month 6
measure: muscle biomarkers
timeFrame: Year 1
measure: mortality
timeFrame: Year 1
measure: morbidity
timeFrame: Year 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Julien Aniort
role: PRINCIPAL_INVESTIGATOR
References: