Muscle Assessment in Stroke Study (MASS): Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 10
- 主要终点
- Change in muscle mass
研究概览
简要总结
The degree of muscle loss over the course of inpatient stay will be evaluated in patients with a diagnosis of acute ischemic stroke admitted to Neurocritical Care Units and necessitating enteral nutrition.
详细描述
This study is a multicenter, prospective observational study. The study period is 12 months. There are no investigational products to be followed or used in the study.
Demographic data, stroke subtype, lesion localization, anthropometric measures will be recorded. Muscle in three different anatomical sites will be measured by CT following admission in patients included in the study.
For anthropometric measurements, height, body weight, body mass index, waist circumference, triceps skin thickness and calf circumference values will be used.
The muscle mass will be measured from the paraspinal muscles at the L3 vertebra level and from the muscles around the humerus and femur on the non-paralytic side of the extremities by CT.
All patients will receive standard enteral nutritional support with a standardized calorie and protein-based protocol recommended by international guidelines. The choice of the commercial enteral product will be left to the investigator, without any encouragement or restriction for use of any commercial product.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients to be included in this study are required to meet all of the following inclusion criteria:
- •Acute ischemic stroke
- •Admission within first 24 hours after symptom onset
- •Admission NIHSS score > 8
- •Being unable to walk
- •Need for enteral tube feeding due to problems with consciousness or dysphagia
排除标准
- •Patients with any of the following exclusion criteria can not be included in the study:
- •Retained ability for oral feeding
- •Known muscle disease, neuropathy, neuromuscular junction disease
结局指标
主要结局
Change in muscle mass
时间窗: 14 days
Comparison of anthropometric measurements and CT based muscle mass measurements obtained at admission and at day 14 (± 3 days)
次要结局
未报告次要终点
研究者
Ethem Murat Arsava
Prof.Dr.
Turkish Stroke Research and Clinical Trials Network
