Characterization of ARDS, Critical Illness Myopathy and Their Long-term Consequences in Patients With Covid-19 Disease: Effects of Inflammation, Mitochondrial Dysfunction and Plasma Concentrations of Various Sedative Drugs
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Short Form (36) Health Survey (SF-36)
研究概览
简要总结
COVID-19 patients with a severely symptomatic progression with development of an Acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing Critical illness myopathy (CIM). CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using (Muscle velocity recovery cycles) MRVC measurements.
The primary endpoint is the incidence of CIM in patients with ARDS due to SARS-CoV-2, diagnosed according to the current diagnostic criteria.
详细描述
COVID-19 patients with a severely symptomatic progression with development of an ARDS due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing CIM. CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using MRVC measurements.
Objective:
The primary objective of this project is to prospectively evaluate the incidence and severity of CIM in patients with ARDS due to SARS-CoV-2.
The secondary objectives of this project include:
- To assess the quality of life of patients with and without CIM after ARDS due to SARS-CoV-2.
- To monitor changes in muscle excitability parameters in critically ill patients with ARDS due to SARS-CoV-2 in relation to a later confirmed diagnosis of CIM according to the current standards.
- To explore underlying pathophysiological processes for CIM (mitochondrial dysfunction, medication e.g. Neuromuscular blocking agents (NMBA), sedative drugs, and metabolic (amino acids, inflammatory parameters)).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent as documented by a surrogate assessment by an independent physician
- •Adult ICU Patients with ARDS due to SARS-CoV-2 requiring mechanical ventilation
排除标准
- •Age <18 years and > 80 years
- •Pregnancy and breast feeding
- •The presence of pre-existing:
- •Known (at time of inclusion) Polyneuropathy,
- •Known (at time of inclusion) Guillain-Barré syndrome,
- •Known (at time of inclusion) Acute or chronic spinal cord lesion,
- •Known (at time of inclusion) Myasthenia gravis, or
- •Known (at time of inclusion) Myopathy
结局指标
主要结局
Short Form (36) Health Survey (SF-36)
时间窗: 3 months
Short Form (36) Health Survey (SF-36)
次要结局
- Barthel Index(3 months)
- Modified Rankin Scale (mRS)(90 days)
- Duration of mechanical ventilation in days(3 months)
- Beck's Depression Inventory II (BDI-II)(3 months)
- Number of patients with Critical Illness Myopathy(day 10)
- Mortality(90 days)
- Essener Questionnaire for Coping with a Disease (EFK)(3 months)