Comparison of Time-restricted Feeding and Continuous Feeding in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- nitrogen balance
研究概览
简要总结
In the nutrition guideline (A.S.P.E.N guideline), there was no recommendation about the feeding type in enteral feeding of critically ill patients. Continuous feeding is the most popular feeding type in ICU because of its less nursing burden and reducing the aspiration incidence theoretically. However, some previous studies demonstrated that there were no complications differences between continuous and time-restricted feedings（such as intermittent feedings）.
In ICU, the disorder of protein synthesis is a universal problem and is associated with ICU acquired weakness. Time-restricted feeding is more physical than continuous feeding. In some animal researches, time-restricted feeding was proved to have a greater stimulatory effect on protein synthesis than continuous feeding. Besides of light, time-restricted feeding can may also adjust the biological rhythms. It is known that biological clocks could affect energy metabolism, emotion and so on. Until now, there are no enough clinical studies to prove the advantages in time-restricted feeding in ICU patients.So researchers designed the study to compare the time-restricted feeding and continuous feeding effect(especially protein synthesis) on ICU patients.
详细描述
Enteral nutrition support can be administered by continuous administration or by time-restricted administration in ICU. Continuous feeding is the most popular feeding schedule because of its less nursing burden and reducing the aspiration prevalence theoretically. However, previous studies demonstrated that there was no complications (diarrhea, distension, Ventilator associated pneumonia-VAP incidence, and so on) difference between these two feeding schedule. So in the nutrition guideline (A.S.P.E.N guideline), there was no recommendation about the feeding schedule. However, time-restricted feeding is more physical than continuous feeding. In ICU, the disorder of protein synthesis is a universal problem and is associated with ICU acquired weakness. In some animal researches, time-restricted feeding was proved to have a greater stimulatory effect on protein synthesis than continuous feeding.
Besides of light, time-restricted feeding can adjust the biological rhythms. It is known that biological clocks could affect energy metabolism, emotion and so on. In the "zi wu liu zhu" theory of traditional chinese medicine, feeding time should be at 7:00-9:00, 11:00-13:00 and 17:00-19:00. So researchers designed the study to compare the time-restricted feeding according to traditional chinese medicine and continuous feeding effect(especially protein synthesis) on ICU patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patients asking for enteral nutrition by gastric tube
排除标准
- •Patients with gastrectomy; patients with enterectomy; patients with Gastrointestinal hemorrhage; patients with diabetes; patients with intestinal fistula
研究组 & 干预措施
continuous feeding
The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24h
干预措施: continuous feeding (Other)
time-restricted feeding
The total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 6h (7:00-9:00,11:00-13:00,17:00-19:00).
干预措施: time-restricted feeding (Other)
结局指标
主要结局
nitrogen balance
时间窗: at the time point of 10th feeding day
it equal to Nitrogen intake minus Nitrogen output.Source of nitrogen intake is the enteral nutritional suspension, and the amount of nitrogen can be calculated according to the proportion of nitrogen in enteral nutritional suspension. Main nitrogen losses include urine and feces. The amount of nitrogen in urine and feces can be measured by clinical laboratory.
次要结局
- glucose fluctuation(up to 10 days)
- Gastric residual volume(up to 10 days)
- Incidence of ventilator-associated pneumonia(up to 10 days)
- delirium(up to 10 days)
- diarrhea(up to 10 days)
- Albumin(up to 10 days)
研究者
Bo Yao,phD
Clinician of intensive care unit, Principal Investigator
Qingdao University