NCT01946841撤回2 期
Effets de la Nutrition entérale spécifique RealDiet®Renal (NES) Chez Des Patients Insuffisants rénaux hémodialysés dénutris : efficacité, tolérance, qualité de Vie.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Lactalis
- 试验地点
- 2
- 主要终点
- Evolution of serum prealbumin and albumin.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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.
结局指标
主要结局
Evolution of serum prealbumin and albumin.
时间窗: 6 months
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.
次要结局
- 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)
研究者
研究点 (2)
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