Back to resultsStudy of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients
Primary Purpose
Renal Insufficiency
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
oral nutritional supplementation
intradialytic parenteral nutrition
Sponsored by
About this trial
This is an interventional supportive care trial for Renal Insufficiency
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.
Sites / Locations
- Hôpital Privé La Louvière
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Membrane PEPA®
Standard membrane of dialysis
Arm Description
Patient will use the membrane PEPA® for the dialysis
Patient will use a standard membrane for the dialysis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evolution of nutritional assessment
Evolution of the percentage of weight loss (in Kg)
Appearance of adverse events
Incidence and characteristics of adverse events / effects
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"
Full Information
NCT ID
NCT04445558
First Posted
June 19, 2020
Last Updated
January 4, 2022
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT04445558
Brief Title
Study of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
June 4, 2021 (Actual)
Study Completion Date
June 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Membrane PEPA®
Arm Type
Experimental
Arm Description
Patient will use the membrane PEPA® for the dialysis
Arm Title
Standard membrane of dialysis
Arm Type
Active Comparator
Arm Description
Patient will use a standard membrane for the dialysis
Intervention Type
Dietary Supplement
Intervention Name(s)
oral nutritional supplementation
Intervention Description
Adjunction of oral nutritional supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
intradialytic parenteral nutrition
Intervention Description
Adjunction of intradialytic parenteral nutrition
Primary Outcome Measure Information:
Title
Evolution of the nutritional status
Description
The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Evolution of nutritional assessment
Description
Evolution of the percentage of weight loss (in Kg)
Time Frame
Month 6
Title
Appearance of adverse events
Description
Incidence and characteristics of adverse events / effects
Time Frame
Month 6
Title
Measure of the Quality of life
Description
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"
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hôpital Privé La Louvière
City
Lille
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of 2 Modalities of Dialysis and Nutrition on the Nutritional Status of Malnourished Chronic Renal Disease Patients
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