NCT04824885

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). ).

Conditions

• End Stage Renal Disease
• Hemodialysis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-15
• Primary completion: 2025-03-06
• Completion: 2025-03-06
• First posted: 2021-04-01
• Last updated: 2025-03-12

Locations

1 site across 1 country: France