Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient (EASY)
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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A measurement of body composition by multi-frequency bioimpedancemetry
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A measurement of the gripping force by a dynamometer (hand grip force )
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A 4-meter walk test
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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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- prealbumin [change at 6 months from the start of Acetate free or acetate containing dialysate]
biochemical measurement
Secondary Outcome Measures
- 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
- SARC-F [change at 6 months from the start of acetate free or acetate containing dialysate]
Result of SARC-F survey
- muscle biomarkers [Month 6]
blood RNA
- muscle biomarkers [Year 1]
blood RNA
- mortality [Year 1]
Time to death
- morbidity [Year 1]
Time to cardiovascular events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Major patient;
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Man or woman ;
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Treated with intermittent hemodialysis for chronic renal failure;
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Affiliated with a social security scheme;
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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:
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Patient with lower limb amputation more proximal than a transmetatarsal amputation (invalidity of the model for estimating body composition by BCM in this situation)
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Acute event in the 3 months preceding inclusion (infection, surgery).
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Having a neuromuscular pathology responsible for a motor deficit.
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Whose life expectancy does not exceed 6 months
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With a psychiatric pathology or cognitive impairment rendering him unable to give informed consent
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Pregnant women
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Patient under guardianship, curatorship or legal protection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Clermont-Ferrand | Clermont-Ferrand | France | 63000 |
Sponsors and Collaborators
- University Hospital, Clermont-Ferrand
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Investigators
- Principal Investigator: Julien Aniort, University Hospital, Clermont-Ferrand
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AOI 2019 ANIORT
- 2020-A00678-31