A Multi-center Randomised Controlled Trial to Explore the Ideal Initial Enteral Feeding Strategies in Patients With Severe Stroke at Acute Stage
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 306
- 试验地点
- 4
- 主要终点
- Rate of patients with death or major disability (modified Rankin scale score ≥3)
研究概览
简要总结
The purpose of this academic lead study is to explore the ideal nutritional support strategy for patient with acute severe stroke.
详细描述
Of high mortality and morbidity, severe stroke is associated with devastating damages in neurologic, respiratory, circulatory and many other systems. The outcomes of patients with severe stroke depend largely on medical strategies on acute stage, especially on nutritional support management. Unfortunately, clinical evidence are sparse and the ideal initial feeding strategy remains disputable.
The IF-STROKE study aims to provide reliable data on the effects of modified full enteral feeding (target recruitment 200) and permissive underfeeding in patients with acute severe stroke (target recruitment 200) compared to full enteral feeding (target recruitment 200). Patients presenting with acute (<72h) severe stroke (GCS ≦ 12 or NIHSS ≧ 11) and dysphagia (defined by Water Swallowing Test) will be randomly assigned to full enteral feeding, modified full enteral feeding, or permissive underfeeding treatment for 7 days.
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
- Single (Participant)
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
- •Severe stroke occurred in 7 days.
- •GCS ≤12 or NIHSS≥
- •Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.
- •Plan to receive enteral feeding for at least 7 days.
- •Informed consent.
排除标准
- •Gastrointestinal diseases before stroke, such as gastrointestinal resection, malabsorption,and irritable bowel syndrome.
- •Brain death.
- •Complicated with the disease which only have life expectancy < 6 months in over 50% patients.
- •After cardiac arrest.
- •Received parenteral nutrition support.
- •Pregnant woman.
- •Concurrent severe hepatic or renal dysfunction。
- •Unstable hemodynamics.
研究组 & 干预措施
Full enteral feeding
The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.
干预措施: Initial enteral feeding (Other)
Modified full enteral feeding
Consistent with full enteral feeding plan, preventively add metoclopramide or mosapride everyday to improve gastrointestinal (GI) motility.
干预措施: Initial enteral feeding (Other)
Modified full enteral feeding
Consistent with full enteral feeding plan, preventively add metoclopramide or mosapride everyday to improve gastrointestinal (GI) motility.
干预措施: metoclopramide or mosapride (Drug)
Permissive underfeeding
The caloric goal of the first day is one-third of caloric requirements, the second day is 40-60% and sustained for 1 week. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.
干预措施: Initial enteral feeding (Other)
结局指标
主要结局
Rate of patients with death or major disability (modified Rankin scale score ≥3)
时间窗: 3 months after enrollment
modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
次要结局
- Mortality (rate of patients with death)(3 months after enrollment)
- The scores of National Institute of Health stroke scale(7 days after enrollment)
- Glasgow Coma Scale(7 days after enrollment)
- modified Rankin scale(3 months after enrollment)
- Barthel index(3 months after enrollment)
- The incidence of treatment intolerance(7 days after enrollment)
- The incidence of serious adverse events(3 months after enrollment)
- The incidence of adverse events That are related to treatment(3 months after enrollment)