Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient (EASY)
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- End Stage Renal Disease
- Hemodialysis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Single (Participant)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 di...
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). ).
Tracking Information
- NCT #
- NCT04824885
- Collaborators
- Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
- Investigators
- Principal Investigator: Julien Aniort University Hospital, Clermont-Ferrand