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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
600
The investigators will consult rehabilitation department for Physical Therapy and patients will be grouped as clinically allocation. Protocols for consideration of initiation The timing is 72 hours after admission to ICU, early mobilization doses and duration is as the protocol of rehabilitation department
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGICU mortality
Status of survival or mortality at the time discharged from ICU
Time frame: The day discharged from ICU, "through study completion, an average of 1 year".
Hospital mortality
Status of survival or mortality at the time discharged from hospital
Time frame: The day discharged from hospital, "through study completion, an average of 1 year".
7-day mortality
Status of survival or mortality at Day 7 during hospital stay
Time frame: Day 7 after hospital admission
28-day mortality
Status of survival or mortality at Day 28 during hospital stay
Time frame: Day 28 after hospital admission
90-day mortality
Status of survival or mortality at Day 90 during hospital stay
Time frame: Day 90 after hospital admission
ICU Days
length of ICU stay
Time frame: During hospitalization, "through study completion, an average of 1 year".
Change of white blood cell between day 1 and day 8
assessing the change of white blood cell count between day 1 and day 8
Time frame: Day 1 and Day8 after ICU admission
Ventilation days
Total using days of mechanical ventilation
Time frame: During hospitalization, "through study completion, an average of 1 year".
Change of percentage of body fat between day 1 and day 8
assessing the change of percentage of body fat between day 1 and day 8 by noninvasively Bio-electrical Impedance Analysis (BIA)
Time frame: Day 1 and Day 8 after ICU admission
Change of total body water between day 1 and day 8
assessing the change of total body water between day 1 and day 8 by noninvasively Bio-electrical Impedance Analysis (BIA)
Time frame: Day 1 and Day 8 after ICU admission
Change of soft lean mass between day 1 and day 8
assessing the change of soft lean mass between day 1 and day 8 by noninvasively Bio-electrical Impedance Analysis (BIA)
Time frame: Day 1 and Day 8 after ICU admission
Concentration of serum IL-6 change between day 1 and day 8
assessing the change of IL-6 between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 1 and Day 8 after ICU admission
Concentration of serum BDNF change between day 1 and day 8
assessing the change of serum BDNF between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 1 and Day 8 after ICU admission
Concentration of serum IL-15 change between day 1 and day 8
assessing the change of serum IL-15 between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 1 and Day 8 after ICU admission
Concentration of serum SPARC change between day 1 and day 8
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)
Time frame: Day 1 and Day 8 after ICU admission
Concentration of serum Irisin change between day 1 and day 8
assessing the change of serum Irisin between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 1 and Day 8 after ICU admission
Concentration of serum Myostatin change between day 1 and day 8
assessing the change of serum Myostatin between day 1 and day 8 by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 1 and Day 8 after ICU admission
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