Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Effica… (NCT01946841) | Clinical Trial Compass
WithdrawnPhase 2
Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life
Stopped: No Patient recruitment
France0Started 2013-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …