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临床试验/NCT04711070
NCT04711070已完成不适用

Understanding the Mechanisms of Critical Illness Myopathy by Use of a Novel Electrophysiological Method - Muscle Velocity Recovery Cycles (MVRCs)

Sándor Beniczky2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年1月4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
42
试验地点
2
主要终点
Muscle relative refractory period (MRRP)

研究概览

简要总结

Critical illness myopathy (CIM) is a disabling condition that develops in critically ill patients. The syndrome is not only a cause of prolonged intensive care hospitalisation but also a main reason for delayed recovery. Critical illness myopathy presents as diffuse muscle weakness and failure to wean from mechanical ventilation.

The pathogenesis of CIM is unclear. The proposed mechanisms for critical illness myopathy include muscle membrane depolarization, circulating depolarizing factor, and an endotoxin that reduces muscle sodium channel availability at depolarized membrane potentials.

The electrophysiological diagnosis of CIM diagnosis is done by electromyography (EMG). In order to be able to detect changes in EMG, more than 2-3 weeks' time is required. Moreover the findings resemble other myopathies and are unspecific. EMG studies in paralysed muscles and sometimes unconscious patients is difficult or even impossible

Since the 1950s, it has been attempted to investigate the muscle cell membrane properties, but it has not been possible to develop a clinically applicable diagnostic method. The novel electrophysiological method MVRCs is a possible future diagnostic method. It's more sensitive to muscle cell membrane changes than existing methods and it is simple enough to use in multiple clinical settings.

The objective of this study is to investigate the utility of MVRCs in the early diagnosis of critical illness myopathy by investigating the muscle membrane properties in sepsis patients, who are in risk of developing CIM. In addition, this will contribute to a better understanding of the pathophysiology of critical illness myopathy.

The study will enrol 70 participants in total, divided in to 2 groups of 20 patients aged ≥18 years; 1) patients with sepsis at intensive care units and 2) patients with chronic renal failure and uremia, and 30 sex- and aged-matched healthy participants. All subjects are to undergo neurological examinations, electromyography, nerve conduction studies, direct muscle stimulation and MVRCs. Blood tests will be taken in all patients. Patients with sepsis will be examined every week in 3 weeks. The presence of probable CIM will be determined on the 4th examination. Healthy participants and patients with chronic renal failure will only be examined in 1 occasion.

The primary outcomes will be MVRCs parameters which will be compared between patients and healthy participants. Furthermore, MVRCs parameters will be correlated to blood sample results.

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: Fulfilled sepsis criteria of an increase in the Sequential (Sepsisrelated) Organ Failure Assessment (SOFA) score of 2 points or more.

排除标准

  • Patients and controls:
  • Earlier peripheral nervous system disease
  • History of malignancy, diabetes mellitus, alcoholism, medicine or other causes of polyneuropathy or myopathy
  • Bleeding tendency or anticoagulation therapy

结局指标

主要结局

Muscle relative refractory period (MRRP)

时间窗: 12 weeks

Measurement of changes in muscle membrane properties by MVRCs.

Early supernormality (ESN)

时间窗: 12 weeks

Measurement of changes in muscle membrane properties by MVRCs.

次要结局

  • Late supernormality (LSN)(12 weeks)
  • Extra late supernormality (XLSN)(12 weeks)

研究者

发起方
Sándor Beniczky
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sándor Beniczky

Professor

Aarhus University Hospital

研究点 (2)

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