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

NCT04445558 | Completed

• 1 other identifier: 2020-A01267-32
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evolution of nutritional assessment

  Month 6

• Appearance of adverse events

  Month 6

• Measure of the Quality of life

  Month 6

Study Arms (2)

Membrane PEPA®

EXPERIMENTAL

Patient will use the membrane PEPA® for the dialysis

Dietary Supplement: oral nutritional supplementation

Standard membrane of dialysis

ACTIVE COMPARATOR

Patient will use a standard membrane for the dialysis

Dietary Supplement: intradialytic parenteral nutrition

Interventions

oral nutritional supplementation DIETARY_SUPPLEMENT

Adjunction of oral nutritional supplementation

Membrane PEPA®

intradialytic parenteral nutrition DIETARY_SUPPLEMENT

Adjunction of intradialytic parenteral nutrition

Standard membrane of dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 not benefiting from a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé La Louvière

Lille, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 24, 2020
• Study Start: July 21, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: January 5, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)