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

End Stage Renal Disease Clinical Trial

— EASY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04824885
• Other study ID #: AOI 2019 ANIORT
• Secondary ID: 2020-A00678-31
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: February 2024

Study information

• Verified date: February 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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). ).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• End Stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prealbumin	biochemical measurement	change at 6 months from the start of Acetate free or acetate containing dialysate
Secondary	Muscle mass	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	change at 6 months from the start of acetate free or acetate containing dialysate
Secondary	Muscle performance	meter walk test	change at 6 months from the start of acetate free or acetate containing dialysate
Secondary	Muscle performance with hand grip test	hand grip test	change at 6 months from the start of acetate free or acetate containing dialysate
Secondary	SARC-F	Result of SARC-F survey	change at 6 months from the start of acetate free or acetate containing dialysate
Secondary	muscle biomarkers	blood RNA	Month 6
Secondary	muscle biomarkers	blood RNA	Year 1
Secondary	mortality	Time to death	Year 1
Secondary	morbidity	Time to cardiovascular events	Year 1