Renal Insufficiency
Conditions
Brief summary
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
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).
Interventions
DIETARY_SUPPLEMENToral nutritional supplementation
Adjunction of oral nutritional supplementation
DIETARY_SUPPLEMENTintradialytic parenteral nutrition
Adjunction of intradialytic parenteral nutrition
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the nutritional status | Month 6 | The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of nutritional assessment | Month 6 | Evolution of the percentage of weight loss (in Kg) |
| Appearance of adverse events | Month 6 | Incidence and characteristics of adverse events / effects |
| Measure of the Quality of life | Month 6 | 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 |
Countries
France
Outcome results
None listed