Study of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Study of Two Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic End-stage Renal Disease Patients Dependent on Intradialytic Parenteral Nutrition

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Dietary Supplement: oral nutritional supplementation
* Dietary Supplement: intradialytic parenteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with renal failure, on hemodialysis for at least 12 months; Hemodialysis patient in 3 weekly sessions on a device with a standard permeability membrane (polysulfone, polyethersulfone or polyartylethersulfone type); Malnourished patient, on intradialytic parenteral nutrition for at least 6 months; Patient who may benefit, according to the doctor, from a change in dialysis and nutrition strategy: Patient who signed an informed consent form to participate in the study Exclusion Criteria: Known allergy to PEPA® ; Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision); Patient with a chronic infection in progress; Patient with life expectancy <6 months according to the investigator; Inability to understand information related to the study (linguistic, psychological, cognitive reason, etc.); Pregnant woman or likely to be (of childbearing age, without effective contraception) or breastfeeding; Patient participating in another clinical trial, or in a period of exclusion from another clinical trial; Patient not benefiting from a social security scheme.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Membrane PEPA®<br>Patient will use the membrane PEPA® for the dialysis | Dietary Supplement: oral nutritional supplementation<br>* Adjunction of oral nutritional supplementation<br>|
| Active Comparator: Standard membrane of dialysis<br>Patient will use a standard membrane for the dialysis | Dietary Supplement: intradialytic parenteral nutrition<br>* Adjunction of intradialytic parenteral nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |