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Completed

NCT Number: NCT04445558

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé La Louvière

Lille, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral nutritional supplementation

Dietary Supplement

Adjunction of oral nutritional supplementation

intradialytic parenteral nutrition

Dietary Supplement

Adjunction of intradialytic parenteral nutrition

Primary outcomes

  1. Evolution of the nutritional status

    Time frame: Month 6

    The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level.

Secondary outcomes

  1. Evolution of nutritional assessment

    Time frame: Month 6

    Evolution of the percentage of weight loss (in Kg)

  2. Appearance of adverse events

    Time frame: Month 6

    Incidence and characteristics of adverse events / effects

  3. Measure of the Quality of life

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2020
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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