The Influences of Duration and Intensity of Early Mobilization on Myokines, Body Composition and Outcomes of Septic Patients in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Hospital mortality
研究概览
简要总结
the investigators' preliminary data revealed that early physical therapy in patients with sepsis in ICU could promote recovery of function (liver and kidney) and decrease the length of stay in hospitalization. The levels of plasma IL-6 and IL-10 were higher in non-survival group than in survival group. the investigators hypothesize that myokines and body composition parameters are related to the prognosis of sepsis.the investigators will investigate the influences of duration and intensity of early mobilization on myokines, body composition and outcomes of septic patients in intensive care. The proposed study can help precision medicine in the future.
详细描述
The septic patients admitted to the intensive care unit (ICU) will be divided into three groups. One is non-PT group, with no physical treatment intervention (group 1), Early-PT group with physical treatment intervention started in ICU admission day 3 (group 2), and Delayed-PT with physical treatment intervention started after ICU admission day 3 (group 3). The grouping will be based on clinical indication for early mobilization (physical therapy) as below. The body composition data (of day 1, 3, 8) of the patients in the three groups will be measured, and the residual blood from day 1 and day 8 will be collected for detecting myokines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Aadmission in ICU
- •Clinical diagnosis of sepsis
排除标准
- •1. Expired in 3-days
- •Cardiac stents or pacemakers
- •Airborne disease
- •Contact-transmitted disease
结局指标
主要结局
Hospital mortality
时间窗: The day discharged from hospital, "through study completion, an average of 1 year".
Status of survival or mortality at the time discharged from hospital
Change of percentage of body fat between day 1 and day 8
时间窗: Day 1 and Day 8 after ICU admission
assessing the change of percentage of body fat between day 1 and day 8 by noninvasively Bio-electrical Impedance Analysis (BIA)
Change of total body water between day 1 and day 8
时间窗: Day 1 and Day 8 after ICU admission
assessing the change of total body water between day 1 and day 8 by noninvasively Bio-electrical Impedance Analysis (BIA)
7-day mortality
时间窗: Day 7 after hospital admission
Status of survival or mortality at Day 7 during hospital stay
28-day mortality
时间窗: Day 28 after hospital admission
Status of survival or mortality at Day 28 during hospital stay
90-day mortality
时间窗: Day 90 after hospital admission
Status of survival or mortality at Day 90 during hospital stay
Change of soft lean mass between day 1 and day 8
时间窗: Day 1 and Day 8 after ICU admission
assessing the change of soft lean mass between day 1 and day 8 by noninvasively Bio-electrical Impedance Analysis (BIA)
Concentration of serum BDNF change between day 1 and day 8
时间窗: Day 1 and Day 8 after ICU admission
assessing the change of serum BDNF between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA)
Concentration of serum IL-15 change between day 1 and day 8
时间窗: Day 1 and Day 8 after ICU admission
assessing the change of serum IL-15 between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA)
ICU mortality
时间窗: The day discharged from ICU, "through study completion, an average of 1 year".
Status of survival or mortality at the time discharged from ICU
ICU Days
时间窗: During hospitalization, "through study completion, an average of 1 year".
length of ICU stay
Change of white blood cell between day 1 and day 8
时间窗: Day 1 and Day8 after ICU admission
assessing the change of white blood cell count between day 1 and day 8
Concentration of serum Irisin change between day 1 and day 8
时间窗: Day 1 and Day 8 after ICU admission
assessing the change of serum Irisin between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA)
Ventilation days
时间窗: During hospitalization, "through study completion, an average of 1 year".
Total using days of mechanical ventilation
Concentration of serum IL-6 change between day 1 and day 8
时间窗: Day 1 and Day 8 after ICU admission
assessing the change of IL-6 between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA)
Concentration of serum SPARC change between day 1 and day 8
时间窗: Day 1 and Day 8 after ICU admission
assessing the change of serum SPARC (secreted protein acidic and rich in cysteine) between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA)
Concentration of serum Myostatin change between day 1 and day 8
时间窗: Day 1 and Day 8 after ICU admission
assessing the change of serum Myostatin between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA)
次要结局
未报告次要终点