Safety and Efficacy of Early Gastrointestinal Decompression for Patients With Acute Severe Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- 90-day Death
研究概览
简要总结
Acute severe ischemic stroke is a life-threatening subtype of stroke. Due to stress ulcer and gastric reflux in acute stage, patients with severe ischemic stroke are always complicated with stomach bleeding and pulmonary infections, resulting in poor prognosis and even death. Reducing stomach acidity and avoiding gastric reflux play a pivotal role on controlling serious complications after austere ischemic attack. Gastrointestinal decompression is an cheap, safe, effective and acknowledgemented strategy for treating stomach bleeding and preventing gastric reflux in clinical settings. Early gastrointestinal decompression seems to be an available method to reduce stomach acidity and avoid gastric reflux after severe ischemic stroke. Therefore, we aimed to evaluate the safety and efficacy of early gastrointestinal decompression in patients with acute severe ischemic stroke.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 18-80 years
- •severe AIS, including NIHSS score>20 in dominant hemisphere infarction, or NIHSS score>15 in non-dominant hemisphere infarction, or NIHSS consciousness score >1; · massive infarction, characterized by infarction area larger than 1/3 of the effected middle cerebral artery territory and/or the cerebellum territory presented in admitted computed tomography (CT) or MRI
- •onset-to-needle time within 24 hours
- •prestroke modified Ranking scales (mRS)≤1
- •sign the informed consent.
排除标准
- •Recent respiratory infection and/or gastrointestinal bleeding
- •austere diseases such as tumors and dyscrasia
- •intention to undergo emergency thrombectomy
- •pregnant women or nursing mother
- •contraindication for gastric tubes
- •participating in other clinical trials within previous 3 months.
结局指标
主要结局
90-day Death
时间窗: 90 days
Death rate at 90 days
次要结局
- 90-day mRS(90 days)
- 30-day mRS(30 days)
- 30-day Barthel scores(30 days)
- 90-day Barthel scores(90 days)
研究者
Jiayue Ding
Principle investigator
Tianjin Medical University General Hospital