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

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Completed

Conditions

Renal Insufficiency

Treatments

Dietary Supplement: intradialytic parenteral nutrition

Dietary Supplement: oral nutritional supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT04445558

2020-A01267-32

Details and patient eligibility

About

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.

Full 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).

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.