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

Primary Purpose

End Stage Renal Disease, Hemodialysis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Acetate free dialysate, hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acetate free then acetate containing dialysate

Acetate containing dialysate then acetate free dialysate

Arm Description

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.

Outcomes

Primary Outcome Measures

prealbumin
biochemical measurement

Secondary Outcome Measures

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
Muscle performance
meter walk test
Muscle performance with hand grip test
hand grip test
SARC-F
Result of SARC-F survey
muscle biomarkers
blood RNA
muscle biomarkers
blood RNA
mortality
Time to death
morbidity
Time to cardiovascular events

Full Information

First Posted
March 23, 2021
Last Updated
February 28, 2022
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
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1. Study Identification

Unique Protocol Identification Number
NCT04824885
Brief Title
Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient (EASY)
Acronym
EASY
Official Title
Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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). ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hemodialysis
Keywords
Acetate free dialysate, hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acetate free then acetate containing dialysate
Arm Type
Experimental
Arm Description
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.
Arm Title
Acetate containing dialysate then acetate free dialysate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)
Intervention Description
usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months
Primary Outcome Measure Information:
Title
prealbumin
Description
biochemical measurement
Time Frame
change at 6 months from the start of Acetate free or acetate containing dialysate
Secondary Outcome Measure Information:
Title
Muscle mass
Description
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
Time Frame
change at 6 months from the start of acetate free or acetate containing dialysate
Title
Muscle performance
Description
meter walk test
Time Frame
change at 6 months from the start of acetate free or acetate containing dialysate
Title
Muscle performance with hand grip test
Description
hand grip test
Time Frame
change at 6 months from the start of acetate free or acetate containing dialysate
Title
SARC-F
Description
Result of SARC-F survey
Time Frame
change at 6 months from the start of acetate free or acetate containing dialysate
Title
muscle biomarkers
Description
blood RNA
Time Frame
Month 6
Title
muscle biomarkers
Description
blood RNA
Time Frame
Year 1
Title
mortality
Description
Time to death
Time Frame
Year 1
Title
morbidity
Description
Time to cardiovascular events
Time Frame
Year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Aniort
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Julien Aniort

12. IPD Sharing Statement

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

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