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

NCT04824885 | Completed

• 2 other identifiers: AOI 2019 ANIORT2020-A00678-31
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

End Stage Renal Disease; Hemodialysis

Keywords

Acetate free dialysate; hemodialysis

Outcome Measures

Primary Outcomes (1)

• prealbumin

  biochemical measurement

  change at 6 months from the start of Acetate free or acetate containing dialysate

Secondary Outcomes (8)

• Muscle mass

  change at 6 months from the start of acetate free or acetate containing dialysate

• Muscle performance

  change at 6 months from the start of acetate free or acetate containing dialysate

• Muscle performance with hand grip test

  change at 6 months from the start of acetate free or acetate containing dialysate

• SARC-F

  change at 6 months from the start of acetate free or acetate containing dialysate

• muscle biomarkers

  Month 6

Study Arms (2)

Acetate free then acetate containing dialysate

EXPERIMENTAL

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)

Acetate containing dialysate then acetate free dialysate

EXPERIMENTAL

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)

Interventions

Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device) 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; Acetate free then acetate containing dialysate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient with lower limb amputation more proximal than a transmetatarsal amputation (invalidity of the model for estimating body composition by BCM in this situation)
• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• INRAE: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julien Aniort

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 1, 2021
• Study Start: February 15, 2022
• Primary Completion: March 6, 2025
• Study Completion: March 6, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

FR (1)