Evaluation de l'efficacité du Support Nutritionnel entéral Intermittent Sur la défaillance d'Organes de Patients de réanimation Sous Ventilation assistée ENteral NUTrition - Continue Intermittent
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score.
研究概览
简要总结
This study aims to evaluate the efficiency of intermittent enteral nutrition versus continuous enteral nutrition to prevent from organ failures for patients at the acute phase of sepsis shock with mechanical ventilation in ICU.
详细描述
Some pre-clinical and observational studies have suggested that intermittent fasting may have a positive impact on patients in ICU by increasing protein synthesis, sensibility to insulin, cetogenesis, autophagy by respecting the circadian rhythm. This study aims to evaluate the impact on organ failures of an intermittent enteral nutrition versus continuous enteral nutrition in patients at the acute phase of sepsis shock with mechanical ventilation in the ICU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 admitted in ICU for less than 48h, with invasive mechanical ventilation predicted for at least 48h, that can undergo nasogastric feeding for 7 days.
- •Patient under vasopressive drugs
- •Adult patients (age ≥ 18 years)
- •Informed person who has read and signed their consent
- •If the patient is unable to sign their consent (emergency situation), the consent will be signed by a trusted person or a family member, and consent to continue the study will be requested subsequently.
- •If the patient is unable to sign their consent (emergency situation) and no trusted person is present, the patient may be included in the study. In this case, consent to continue the study will be requested from a trusted person as soon as possible, or from the patient if they are able to understand and sign the consent.
- •Affiliation to a social security scheme
- •No current pregnancy: for women of childbearing age, a beta-HCG blood pregnancy test will be performed upon inclusion; for postmenopausal women, a confirmatory diagnosis must be obtained.
排除标准
- •Contraindication to enteral nutrition and/or nasogastric tube insertion: esophageal varices and occlusive syndrome
- •Artificial enteral nutrition that cannot be initiated within 48 hours of intubation
- •Enteral nutrition ongoing for more than one hour at the time of inclusion
- •Need for exclusive or supplemental parenteral nutrition
- •Moribund patient
- •Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship
- •Pregnant or breastfeeding woman
研究组 & 干预措施
continuous enteral nutrition
patients that receive continuous enteral nutrition
Intermittent enteral nutrition
patients that receive intermittent enteral nutrition.
干预措施: Intermittent enteral nutrition (Other)
结局指标
主要结局
Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score.
时间窗: day-1 (nutrition start) and day-7
Comparison of variation of the SOFA score between patients with intermittent nutrition versus patients with continuous nutrition.
次要结局
- Evaluation of death(from day 1 to day 90)
- evaluation of caloric intake(from day-1 (nutrition start) to day-7)
- evaluation of protein intake(from day-1 (nutrition start) to day-7)
- Measurement of nutritionnal status(day-1 (nutrition start) and day-7)
- Evaluation of the digestive tolerance(from day-1 (nutrition start) to day-7)
- Evaluation of the metabolic response(day 1, day 4 and day 7)
- Evaluation of quality of life(up to day 90)
- Evaluation of the nosocomial infections(from day-1 (nutrition start) to day-7)
- Adverse events(from day-1 (nutrition start) to day-7)
- Evaluation of the duration of hospitalisation(day 1 to day 90)
- Evaluation of the intensive care neuromuscular weakness(Up to day 10)