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

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

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.

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.