Status:
COMPLETED
Study of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
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 d...
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 stat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04445558
Start Date
July 21 2020
End Date
June 4 2021
Last Update
January 5 2022
Active Locations (1)
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1
Hôpital Privé La Louvière
Lille, France