Clinical trial NCT01946841: Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life
Official title: Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Chronic Kidney Disease
Renal Failure Chronic Requiring Hemodialysis
Severe Malnutrition
Tolerance
Quality of Life
Activity
Appetite and General Nutritional Disorders
Keywords: Chronic kidney disease
Hemodialysis
Severe malnutrition
Enteral nutrition
Lead sponsor: Lactalis
Sponsor class: INDUSTRY
Collaborators: name: Clinact
First posted: 2013-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evolution of serum prealbumin and albumin.
timeFrame: 6 months
Secondary outcomes:
measure: Evolution of nutritional status during 3 months of enteral nutrition, and during 3 months after end of treatment.
timeFrame: 6 months
measure: Evolution of quality of life during 3 months of enteral nutrition, and during 3 months after end of treatment.
timeFrame: 6 months
measure: Evolution of tolerance of study product during 3 months of enteral nutrition.
timeFrame: 3 mois
Other outcomes:
Locations:
city: Retiers
country: France
facility: Lactalis
Study officials:
References: