Daytime Cyclic Enteral Nutrition Versus Standard Continuous Enteral Nutrition in the Intensive Care Unit: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 6
- 主要终点
- Change of organ failures
研究概览
简要总结
Critical care patients experience systemic aggression, which may be the result of trauma, infection or other systemic inflammatory mechanisms. The initial phase of their illness is characterized by metabolic instability and increased catabolism. Nutrition goals in these patients are therefore, on the one hand, to provide sufficient caloric intake to cover energy expenditure while limiting the risks of inappropriate under-feeding, overfeeding- or re-feeding syndrome, and on the other hand, to meet the protein requirements linked to hypercatabolism. In the absence of contraindication, current recommandations state that an intensive care patient who cannot be fed orally, shoul receive continuous enteral nutrition over 24 hours by gastric tube within 48 hours of admission.
However, this 24-hour continuous nutrition method does not correspond to the physiological habit of the human species which includes a physiological nighttime fasting period.This fasting period induces a metabolic switch that regulates several pathways, including glycemic control, oxidative stressresistance and deoxyribonucleic acid (DNA) repair. Furthermore, it takes part un the synchronization of cellular circadian rhythms.
Investigator hypothetises that diurnal cyclic enteral nutrition may improve the prognosis of severe intensive care patients compared to continuous enteral nutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patient aged 18 years and over admitted to intensive care
- •On invasive mechanical ventilation for less than 24 hours
- •With an indication for exclusive enteral feeding by naso- or oro-gastric tube
- •With an expected remaining duration of mechanical ventilation > 72 hours
排除标准
- •Enteral feeding via tube already started
- •Parenteral nutrition in progress or deemed necessary by the practitioner
- •Active digestive haemorrhage as evidenced by fibroscopy or with need for transfusion
- •Digestive surgery less than one month old
- •History of mesenteric ischaemia
- •History of gastrectomy, oesophagectomy, duodenopancreatectomy, bariatric surgery, short bowel syndrome
- •Pregnant, lactating or parturient woman
- •Body mass index < 18 kg/m2
- •Person deprived of liberty by judicial or administrative decision, person under forced psychiatric care, person under legal protection (guardianship or curatorship)
- •Lack of social security coverage
- •Lack of consent or emergency procedure form
- •Patient participating in another randomised clinical research study on feeding of resuscitation patients
结局指标
主要结局
Change of organ failures
时间窗: Day 7
Change is measured by evolution of the Sequential Organ Failure Assessment (SOFA) score at D7 compared with D0 in both groups
次要结局
- Mortality(At Day 28)
- Days intubated(Day 1 to Day 28)
- Average daily caloric intake(Day 1 to Day 7)
- Proportion of patients achieving > 80% of their recommended caloric intake at D7(Day 7)
- Average daily protein intake(Day 1 to Day 7)
- Vomiting(Day 1 to Day 10)
- Diarrhea(Day 1 to Day 10)
- Constipation(Day 1 to Day 10)
- Intestinal ischemia(Day 1 to Day 10)
- Ventilator acquired pneumonia(Day 1 to Day 10)
- Insulin consumption(Day 1 to Day 7)
- Hypoglycemia(Day 1 to Day 7)
- Bilirubin(Day 1 to Day 7)
- Urea(Day 1 to Day 7)
- Days without mechanical ventilation(Day 1 to Day 28)
- Lactatemia(Day 1 to Day 7)
- Ketonemia(Day 1 to Day 7)