The Effect of Time-restricted Enteral Nutrition on the Prognosis of Severe Stroke Patients: a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Poor 90-day functional prognosis
研究概览
简要总结
In patients with severe stroke whose GCS score is ≤12 points or NIHSS score is ≥11 points, to evaluate whether time-restricted enteral nutrition can improve the incidence of poor 90-day prognosis (mRS ≥3 points) compared with continuous enteral nutrition.
详细描述
Control the daily enteral nutrition time to 8-12 hours, enteral nutrition start time: 06:00 ~ 08:00, end time: 16:00 ~ 18:00. Enteral nutrition lasts until the patient discontinues enteral nutrition, the patient dies, the patient is transferred from the ICU, or enteral nutrition is used until 28 days, whichever event occurs first.
On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.
The control group was continuous enteral nutrition (24 hours), which lasted until the patient stopped taking enteral nutrition, the patient died, the patient was transferred from the ICU, or enteral nutrition was used until 28 days, whichever event occurred first.
On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old and <80 years old;
- •Cerebral parenchymal hemorrhage or cerebral infarction within 72 hours of onset;
- •GCS score ≤12 points or NIHSS score ≥11 points on admission,
- •Enteral nutrition is planned, and the estimated enteral nutrition treatment time is ≥7 days;
- •Signed informed consent form.
排除标准
- •Complete parenteral nutrition is required due to contraindications to enteral nutrition;
- •After gastrectomy or intestinal resection;
- •Enteral nutrition treatment has been performed for >12 hours;
- •Accompanying diseases: a. Advanced cancer; b. Severe cardiac insufficiency [ejection fraction ≤ 50%]; c. Severe liver failure [Child Pugh score ≥ 7]; d. Severe renal failure [glomerular filtration] rate ≤ 30 mL/min or serum creatinine ≥ 4 mg/dL])
- •Have a history of mental illness or mRS ≥ 3 points;
- •The patient's doctor or nutritional therapist believes that the plan is not in the best interest of the patient;
- •During the patient's admission, death is inevitable, and there are underlying diseases that result in a survival time of <90 days;
- •The patient participates in another clinical study.
研究组 & 干预措施
Time-restricted group
Time-restricted enteral nutrition therapy group
干预措施: Time-restricted enteral nutrition therapy group (Other)
Continuous group
Continuous enteral nutrition control group
干预措施: Continuous enteral nutrition control group (Other)
结局指标
主要结局
Poor 90-day functional prognosis
时间窗: Day 90 post-randomization
mRS ≥ 3 points
次要结局
- GCS score at discharge(The day of Discharge, an average of 20 days)
- NIHSS score at discharge(The day of Discharge, an average of 20 days)
- mRS score at discharge(The day of Discharge, an average of 20 days)
- Barthel index at discharge(The day of Discharge, an average of 20 days)
- 90-day Barthel Index(Day 90 post-randomization)
- ICU length of stay(From admission to ICU to transfer out of ICU .an average of 11 days)
- Length of hospital stay(The day of Discharge, an average of 20 days)