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

NCT ID: NCT04445558

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-21
• Study Completion Date: 2021-06-04

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).

Conditions

Renal Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Membrane PEPA®

Patient will use the membrane PEPA® for the dialysis

Group Type: EXPERIMENTAL

oral nutritional supplementation

Intervention Type: DIETARY_SUPPLEMENT

Adjunction of oral nutritional supplementation

Standard membrane of dialysis

Patient will use a standard membrane for the dialysis

Group Type: ACTIVE_COMPARATOR

intradialytic parenteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

Adjunction of intradialytic parenteral nutrition

Interventions

oral nutritional supplementation

Adjunction of oral nutritional supplementation

Intervention Type: DIETARY_SUPPLEMENT

intradialytic parenteral nutrition

Adjunction of intradialytic parenteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Privé La Louvière

Lille, , France

Countries

France

Other Identifiers

2020-A01267-32

Identifier Type: -

Identifier Source: org_study_id