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

NCT ID: NCT04824885

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2025-03-06

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). ).

Conditions

End Stage Renal Disease; Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)

Intervention Type: DEVICE

usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months

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.

Group Type: EXPERIMENTAL

Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)

Intervention Type: DEVICE

usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

INRAE

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien Aniort

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Other Identifiers

2020-A00678-31

Identifier Type: OTHER

Identifier Source: secondary_id

AOI 2019 ANIORT

Identifier Type: -

Identifier Source: org_study_id