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临床试验/NCT01521637
NCT01521637已完成不适用

The Efficacy of Neuromuscular Electrical Stimulation to Attenuate Skeletal Muscle Loss in ICU Patients

Hasselt University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2012年1月1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
15
试验地点
1
主要终点
Change in muscle fiber cross sectional area (CSA)

研究概览

简要总结

Subjects who are hospitalized in the ICU will be included after 24 hours of intubation during their ICU stay. Twice-daily Neuromuscular Electrical Stimulation (NMES) will be performed on one leg for 2x40 min per day to assess muscle fiber size. The investigators hypothesize an attenuated loss in muscle fiber size.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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
Male
接受健康志愿者

入选标准

  • Age between 18 and 80 years
  • Expected sedated time of >24h

排除标准

  • Spinal Cord Injury
  • Arterial operaties on the legs
  • Local wounds that prohibit NMES
  • Chronic use of corticosteroids
  • Intake of certain antithrombotic drugs
  • Presence of implantable cardioverter defibrillator and/or pacemaker

结局指标

主要结局

Change in muscle fiber cross sectional area (CSA)

时间窗: 3 hours before and 12 hours after 10 days of twice-daily NMES

Muscle fiber cross sectional area (in um2) for type I and II fibers will be analyzed by using immunohistochemistry; the change of muscle fiber CSA over time will be measured

次要结局

  • Change in upper leg circumference(3 hours before and 12 hours after 10 days of twice-daily NMES)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dominique Hansen

PhD

Hasselt University

研究点 (1)

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