Hôpital Privé La Louvière
Lille, France
NCT Number: NCT04445558
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Lille, France
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Adjunction of oral nutritional supplementation
Adjunction of intradialytic parenteral nutrition
Time frame: Month 6
The main endpoint is the evolution between M0 and M6 of the nutritional status measured by the serum albumin level.
Time frame: Month 6
Evolution of the percentage of weight loss (in Kg)
Time frame: Month 6
Incidence and characteristics of adverse events / effects
Time frame: Month 6
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"
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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