Difference of Muscle Power and Myokine Profile After Upper Limb or Lower Limb Electric Muscle Stimulation in Patients With Severe Sepsis and Acute Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Ventilator-dependant Days
研究概览
简要总结
Rationale : Electric muscle stimulation reduced critical-illness related weakness in patients with severe sepsis and septic shock. But optimal protocol of the stimulation in unknown.
Hypothesis: Focal muscle contraction may improved the muscle power and have systemic anti-inflammatory via cytokine secretion . The difference of electricity used in upper limb or lower limb stimulation may lead to different effect.
Study design: Stratified randomized parallel control study, comparing Biceps, Quadriceps electric muscle stimulation vs. non-stimulation group.
Participant: adult patients with severe sepsis and acute respiratory failure requiring mechanical ventilation.
Intervention: daily stimulation of bilateral Biceps or Quadriceps by programmed electric devices 32 minutes, 5 days/week
Outcome:
- Primary outcome: Ventilator-dependent days
- Secondary outcome: change of hand drip muscle power/interleukin-1b/interleukin-6/interleukin-8/TNF-alpha
详细描述
Background : Severe sepsis and septic shock remain top cause of admission to intensive care unit. Muscle weakness was found in 70-100% patients with severe sepsis and septic shock because of critical-illness induced polyneuropathy and myopathy. Previous study revealed electric muscle stimulation (EMS) could reduce such muscle weakness and mechanical ventilator-dependent days.
Hypothesis
different electricity may be needed for minimal contraction of upper or lower limb because of their muscle size. Induced muscle contraction may lead to myokine secretion and beneficial metabolic and anti-inflammatory effect. Stimulation on Quadriceps may be better than on Biceps.
Participant: adult(older than 20 years-old) patients with severe sepsis.septic shock and acute respiratory failure post mechanical ventilation.
Design: Stratified ( gender and age >50 years-old) Randomized parallel 3 arms study.
Intervention: Daily stimulation of Biceps of Quadriceps after third days in intensive care unit. Programmed electric stimulation device ( HELEX 573 model, strength aggressive. mode, 45-55Hz 32 minutes per day, voltage 30-70mA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe sepsis or septic shock patients with acute respiratory failure more than 3 days
- •adult patients( age>20 years-old)
排除标准
- •skin wound/infection near the site of muscle stimulation
- •acute myocardial infarction within 7 days
- •pregnant women
- •uncontrolled epilepsy
- •no spontaneous breath because of central or cervical spinal neuropathy
研究组 & 干预措施
Quadriceps stimulation
EMS
干预措施: EMS (Device)
Biceps stimulation
EMS
干预措施: EMS (Device)
Control
Control group without electric muscle stimulation
结局指标
主要结局
Ventilator-dependant Days
时间窗: 21 days
Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)
次要结局
- Muscle Strength Improvement(21 days)
研究者
Kuang-Hua Cheng, MD
visiting staff of pulmonary medicine
Mackay Memorial Hospital