Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life (AL-EN-PHED)
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ClinicalTrials.gov Identifier: NCT01946841
(No Patient recruitment)
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.
Condition or disease
Chronic Kidney DiseaseRenal Failure Chronic Requiring HemodialysisSevere MalnutritionToleranceQuality of LifeActivityAppetite and General Nutritional Disorders
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
NPNA <1 g / kg / day for 2 consecutive months
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
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)
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.