跳至主要内容
临床试验/NCT01321320
NCT01321320已完成不适用

Investigation of the Role of FHL-1 and Myostatin in the Development of Intensive Care Unit Acquired Paresis (ICUAP) and the Effect of Increased Muscle Activity on These Pathways.

Imperial College London1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Change in muscle myostatin and FHL-1

研究概览

简要总结

The primary hypothesis for this study is that Myostatin and FHL-1 are important in the development of ICUAP and that changes in activity levels of muscle will modify the levels of expression and activity of these proteins.

详细描述

ICUAP is an increasingly recognised clinical problem associated with significant morbidity and mortality. However the pathogenesis of the diseae is poorly understood and as yet no treatment exists. We believe that both myostatin and FHL-1 will be important in the development of this disease. This is based recent research and that both these proteins are likely to be regulated by sepsis and immobility (two major risk factors for ICUAP. There is evidence from invitro work that the two are likely to interact. We have designed an interventional trial to investigate the above hypothesis. Patients admitted to ICU and at risk of developing muscle wasting will be selected and receive electrical muscle stimulation of the quadriceps muscle for 1 week. Physiological measurements of peripheral and respiratory muscle strength and quadriceps size will be made pre and post intervention. And muscle biopsies, blood and urine collected from both legs pre and post intervention. The relevant molecular pathways can then be examined.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
Single (Investigator)

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

  • High risk patients admitted to AICU.

排除标准

  • Pre existing neuromuscular disease.

结局指标

主要结局

Change in muscle myostatin and FHL-1

时间窗: 1 week

次要结局

  • Change in blood myostatin, miRNA and other markers of muscle breakdown(1 week)
  • Change in quadriceps cross sectional area(1 week)
  • Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples.(1 week)
  • Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received.(1 week)
  • Change in quadriceps strength(1 week)
  • Change in muscle phenotype and change in cross sectional area for individual fiber types(1 week)

研究者

申办方类型
Other

研究点 (1)

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