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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00678-31 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| INRAE | UNKNOWN |
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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
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:
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). ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| prealbumin | biochemical measurement | change at 6 months from the start of Acetate free or acetate containing dialysate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Muscle performance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julien Aniort | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
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meter walk test |
| change at 6 months from the start of acetate free or acetate containing dialysate |
| Muscle performance with hand grip test | hand grip test | change at 6 months from the start of acetate free or acetate containing dialysate |
| SARC-F | Result of SARC-F survey | change at 6 months from the start of acetate free or acetate containing dialysate |
| muscle biomarkers | blood RNA | Month 6 |
| muscle biomarkers | blood RNA | Year 1 |
| mortality | Time to death | Year 1 |
| morbidity | Time to cardiovascular events | Year 1 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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