Effects of Electrical Stimulation for Preventing Loss of Muscle Mass in Patients With SIRS, Sepsis and Septic Shock - Randomized, Controlled and Double-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Muscle mass
研究概览
简要总结
Background: Electrical stimulation has been used in critical patients as an adjunct strategy of early rehabilitation. In septic or septic shock patients there are reports of only two studies in the literature, with conflicting results.
Objective: To evaluate the effects of electrical stimulation in the prevention of muscle mass loss in patients admitted to the ICU with systemic inflammatory response syndrome (SIRS), sepsis or septic shock.
Methods: This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group. They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.
Expected results: Electrical stimulation is expected to be able to prevent loss of muscle mass in patients admitted to the ICU with SIRS, sepsis or septic shock. In addition, it is expected to be able to preserve strength in this population without increasing the pro-inflammatory or metabolic response.
详细描述
This is a randomized, controlled, double-blind clinical trial. Thirty-six patients with a diagnosis of SIRS, sepsis or septic shock (including patients with sepsis due to the new coronavirus - COVID-19) will be randomly assigned to experimental group and sham group.They will be evaluated in relation to muscle mass, peripheral muscle strength and functional status. They will also be submitted to the collection of inflammatory, metabolic, damage and muscular trophism markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients admitted to the ICU with a diagnosis of SIRS, sepsis or septic shock,
- •aged ≥ 18 years,
- •body mass index (BMI) ≤ 35 kg / m2,
- •without diabetic polyneuropathy,
- •without cardiac pacemaker,
- •without diagnosis of neuromuscular diseases,
- •absence of skin lesions.
排除标准
- •heart attack,
结局指标
主要结局
Muscle mass
时间窗: 8 days
Cross-sectional area
次要结局
- Peripheral muscle strength(8 days)
- Functional status(8 days)
- Inflammatory(5 days)
- Metabolic, damage and muscular trophism markers(5 days)
研究者
Wellington Yamaguti
Wellington Pereira dos Santos Yamaguti
Hospital Sirio-Libanes