Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient (EASY)
- Conditions
- End Stage Renal DiseaseHemodialysis
- Interventions
- Device: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)
- Registration Number
- NCT04824885
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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). ).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Acetate free then acetate containing dialysate Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device) 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. Acetate containing dialysate then acetate free dialysate Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device) 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.
- Primary Outcome Measures
Name Time Method prealbumin change at 6 months from the start of Acetate free or acetate containing dialysate biochemical measurement
- Secondary Outcome Measures
Name Time Method muscle biomarkers Year 1 blood RNA
mortality Year 1 Time to death
morbidity Year 1 Time to cardiovascular events
SARC-F change at 6 months from the start of acetate free or acetate containing dialysate Result of SARC-F survey
Muscle mass change at 6 months from the start of acetate free or acetate containing dialysate 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
Muscle performance change at 6 months from the start of acetate free or acetate containing dialysate meter walk test
Muscle performance with hand grip test change at 6 months from the start of acetate free or acetate containing dialysate hand grip test
Trial Locations
- Locations (1)
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France