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

Not Applicable

Completed

• Conditions: Renal Insufficiency
• Interventions: Dietary Supplement: oral nutritional supplementation; Dietary Supplement: intradialytic parenteral nutrition

• Registration Number: NCT04445558
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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).

Study Timeline

• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Study Start: 2020-07-21
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Membrane PEPA®	oral nutritional supplementation	Patient will use the membrane PEPA® for the dialysis
Standard membrane of dialysis	intradialytic parenteral nutrition	Patient will use a standard membrane for the dialysis

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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"
Evolution of nutritional assessment	Month 6	Evolution of the percentage of weight loss (in Kg)

Trial Locations

Locations (1)

Hôpital Privé La Louvière; 🇫🇷 Lille, France