Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life

Study Overview
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Brief Summary
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The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.

Official Title
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Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.

Conditions
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Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis, Severe Malnutrition, Tolerance, Quality of Life, Activity, Appetite and General Nutritional Disorders

Intervention / Treatment
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* Dietary Supplement: RealDiet®Renal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic kidney disease patient on hemodialysis for at least 3 months, with a minimum of three hemodialysis sessions of 4 hours per week Patients aged 18 years Written, free and informed consent given by the Patient Patient insured under the social security system or equivalent Patients who did not receive enteral nutrition during the 3 months preceding inclusion ; taking an oral nutritional supplement, or per-dialytic parenteral nutrition or total parenteral nutrition is not a criterion of non-inclusion Patient in a state of malnutrition defined by the presence of at least 3 out of 5 of the following criteria : weight loss greater than 10% observed in the last six months serum albumin <35 g / l serum Prealbumin <300 mg / l BMI <20 NPNA <1 g / kg / day for 2 consecutive months and presenting food intake <20 kcal / kg / day or failure of other nutritional care methods, namely, oral nutritional supplements and / or peridialytic parenteral nutrition, or total parenteral nutrition lack of compliance after one month, to the nutritional care methods mentioned above. • Patients for whom the decision to prescribe enteral feeding was previously taken Exclusion Criteria: Patients with a history of intolerance to enteral feeding Index Kt/Veq (balanced) < or = 1.2 or index Kt/Vsp (single pool) < or = 1.4 according to the method used Patients with a disease compromising the short-term (4-6 months) prognosis (cancer or other disease in the terminal phase) Pregnant Patient Patient with a known allergy to at least one of the following : milk protein, soy, fish Patient whose digestive tract is not functional or patient in shock Patient protected under guardianship Patient in exclusion period after participation in another clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RealDiet®Renal enteral nutrition<br> | Dietary Supplement: RealDiet®Renal<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of serum prealbumin and albumin. | Evaluate during 3 months specific enteral nutrition (SEN) treatment, and 3 months after treatment interruption, the effects of the study product on the evolution of serum prealbumin and albumin. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment. |  | 6 months | 
| Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment. |  | 6 months | 
| Evolution of tolerance of study product during 3 months of enteral nutrition. |  | 3 mois | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic kidney disease, Hemodialysis, Severe malnutrition, Enteral nutrition