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临床试验/NCT03825419
NCT03825419已完成不适用

Muscle Assessment in Stroke Study (MASS): Detection of Muscle Loss in Acute Stroke Patients Who Need Enteral Nutrition

Turkish Stroke Research and Clinical Trials Network10 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2019年1月23日最近更新:
适应症

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

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

发起方
Turkish Stroke Research and Clinical Trials Network
申办方类型
Network
责任方
Principal Investigator
主要研究者

Ethem Murat Arsava

Prof.Dr.

Turkish Stroke Research and Clinical Trials Network

研究点 (10)

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