Trophic Enteral Feeding Combined With Supplemental Parenteral Nutrition Treatment in Patients With Severe Stroke (OPENS-2): a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 546
- 试验地点
- 30
- 主要终点
- Incidence of post stroke pneumonia
研究概览
简要总结
Post stroke pneumonia (PSP) is one of the common early complications of stroke. Post-stroke infections, in general, are associated with less favorable neurologic outcomes. Aspiration is one of the most feared complications of enteral nutrition and can lead to the occurrence of pneumonia. Severe stroke patients are at high risk for aspiration due to some factors such as the reduced level of consciousness, inability to protect the airway and so on. The purpose of this study is to explore the ideal nutrition support strategy for patient with acute severe stroke to help reduce the incidence of PSP and improve the prognosis.
详细描述
As one of the most common complication of stroke, some studies showed that post-stroke pneumonia (PSP) in stroke patients requiring intensive care is associated with an increase of ICU length of stay and hospital mortality and poorer functional outcomes in survivors. The peak period of PSP is within the first week after stroke. Aspiration and poor nutritional status are important factors leading to pneumonia in stroke patients. Compared with full enteral nutrition (EN), initial trophic enteral feeding was associated with less gastrointestinal intolerance and could reduce the rate of regurgitation. However, trophic enteral feeding could not meet the daily caloric needs and hypocaloric enteral nutrition might be associated with increased mortality. This study is designed to explore whether initial trophic enteral nutrition combined with supplemental parenteral nutrition (SPN) can help reduce the incidence of PSP and improve the prognosis in severe patients with stroke.
This study will enroll 546 severe stroke patients who meet the inclusion criteria. Upon admission to the ICU, patients will be randomly assigned at a 1:1 ratio into groups of full enteral feeding (controlled) and trophic enteral feeding combined with supplemental parenteral feeding (experimented) 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 (Outcomes Assessor)
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
- •Age≥18 years
- •Definite diagnosis of acute stroke (GCS ≤12 or NIHSS≥11)
- •The randomized nutritional treatment could be initiated up to 72 hours after symptom onset.
- •Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.
- •Plan to receive nutritional support treatment for at least 7 days.
- •Informed consent.
排除标准
- •Receiving parenteral nutrition support
- •Contraindications of enteral nutrition
- •Complicated with the disease which only have life expectancy < 7 days
- •Admission with infection signs
- •Dementia or severe disability (mRS>4) before stroke
- •Antibiotics were used within the previous 7 days
- •Subarachnoid hemorrhage, cerebral arteriovenous malformation
- •Presence of coexisting medical conditions that could interfere with outcome assessment and/or follow-up (a. advanced cancer; b. severe pulmonary dysfunction [forced expiratory volume in 1 second < 50% or/and moderate to severe acute lung injury (PaO2/FiO2)<200mmHg]; c. cardiac insufficiency (NYHA class > I; cardiac structural and/or functional abnormalities such as EF< 50%, abnormal cardiac chamber enlargement, moderate/severe ventricular hypertrophy, or moderate/severe valvular stenosis); d. Severe liver failure [Child-Pugh score≥7]; e. Severe renal failure [glomerular filtration rate ≤30mL/min or serum creatinine ≥4mg/dL]
- •Currently participating in other clinical trial
- •Pregnant woman
- •Patient who is considered highly likely not to adhere to the study treatment or follow-up protocol.
研究组 & 干预措施
Full enteral feeding
Patients will receive full enteral feeding through nasogastric tube or nasointestinal tube.
干预措施: Full enteral feeding (Procedure)
Trophic enteral feeding combined with supplemental parenteral nutrition
Patients will receive trophic enteral feeding combined with supplemental parenteral feeding.
干预措施: Trophic enteral feeding combined with supplemental parenteral nutrition (Procedure)
结局指标
主要结局
Incidence of post stroke pneumonia
时间窗: up to 7 days
次要结局
- modified Rankin scale(90 days after enrollment)
- Insulin utilization(up to 7 days)
- The use of vasoactive agents(1 day of ICU discharge)
- The score of National Institute of Health stroke scale at ICU discharge(1 day of ICU discharge)
- Glasgow Coma Scale at ICU discharge(1 day of ICU discharge)
- The time from randomisation to the onset of the post stroke pneumonia(up to 7 days)
- Daily protein delivery(up to 7 days)
- The use of prokinetic agents(up to 7 days)
- The length of ICU stay(1 day of ICU discharge)
- Mortality(1 day of ICU discharge)
- Daily calorie delivery(up to 7 days)
- The incidence of gastrointestinal complications(up to 7 days)
- Mechanical ventilation(1 day of ICU discharge)
- Deep venous thrombosis(1 day of ICU discharge)
- modified Rankin scale at ICU discharge(1 day of ICU discharge)
- Cardiac failure(1 day of ICU discharge)
- The occurrence of infections(1 day of ICU discharge)
- The All-cause mortality rate(28 days after enrollment)
- Tracheotomy(1 day of ICU discharge)
- Continuous renal replacement therapy(1 day of ICU discharge)
研究者
Wen Jiang-3
Head of Neurology
Xijing Hospital