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Describe the impact of dialysis by high permeability and adsorbent membrane (PEPA®) associated with oral nutritional supplementation on the nutritional status of malnourished chronic end-stage renal disease patients dependent on intradialytic parenteral nutrition.
The study proposes to compare the nutritional state after 6 months of dialysis with standard membrane associated with intradialytic parenteral nutrition (retrospective phase) with the nutritional state after 6 months of dialysis with high permeability membrane associated with oral nutritional supplementation (prospective phase).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Membrane PEPA® | Experimental | Patient will use the membrane PEPA® for the dialysis |
|
| Standard membrane of dialysis | Active Comparator | Patient will use a standard membrane for the dialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral nutritional supplementation | Dietary Supplement | Adjunction of oral nutritional supplementation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the nutritional status | The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of nutritional assessment | Evolution of the percentage of weight loss (in Kg) | Month 6 |
| Appearance of adverse events | Incidence and characteristics of adverse events / effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé La Louvière | Lille | France |
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| intradialytic parenteral nutrition | Dietary Supplement | Adjunction of intradialytic parenteral nutrition |
|
| Month 6 |
| Measure of the Quality of life | Evolution of the quality of life, evaluated by the EORTC QLQ-C30 questionnaire of the quality of life with 28 questions with 4 possible answers from "not at all" to "a lot of" | Month 6 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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