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

Renal Insufficiency Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445558
• Other study ID #: 2020-A01267-32
• Status: Completed
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: June 4, 2021

Study information

• Verified date: January 2022
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 4, 2021
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Dietary Supplement:
• oral nutritional supplementation
Adjunction of oral nutritional supplementation
• intradialytic parenteral nutrition
Adjunction of intradialytic parenteral nutrition

Locations

Country	Name	City	State
France	Hôpital Privé La Louvière	Lille

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evolution of nutritional assessment	Evolution of the percentage of weight loss (in Kg)	Month 6
Secondary	Appearance of adverse events	Incidence and characteristics of adverse events / effects	Month 6
Secondary	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