Clinical trial NCT06061224: The Influences of Early Mobilization on Myokines, Body Composition and Outcomes in ICU Septic Patients
Official title: The Influences of Duration and Intensity of Early Mobilization on Myokines, Body Composition and Outcomes of Septic Patients in Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Keywords: sepsis
early mobilization
myokines
body composition
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 1. Aadmission in ICU 2. Clinical diagnosis of sepsis

Exclusion Criteria:

* 1. Expired in 3-days 2. Cardiac stents or pacemakers 3. Airborne disease 4. Contact-transmitted disease

Primary outcomes:
measure: ICU mortality
timeFrame: The day discharged from ICU, "through study completion, an average of 1 year".
measure: Hospital mortality
timeFrame: The day discharged from hospital, "through study completion, an average of 1 year".
measure: 7-day mortality
timeFrame: Day 7 after hospital admission
measure: 28-day mortality
timeFrame: Day 28 after hospital admission
measure: 90-day mortality
timeFrame: Day 90 after hospital admission
measure: ICU Days
timeFrame: During hospitalization, "through study completion, an average of 1 year".
measure: Change of white blood cell between day 1 and day 8
timeFrame: Day 1 and Day8 after ICU admission
measure: Ventilation days
timeFrame: During hospitalization, "through study completion, an average of 1 year".
measure: Change of percentage of body fat between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Change of total body water between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Change of soft lean mass between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Concentration of serum IL-6 change between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Concentration of serum BDNF change between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Concentration of serum IL-15 change between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Concentration of serum SPARC change between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Concentration of serum Irisin change between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
measure: Concentration of serum Myostatin change between day 1 and day 8
timeFrame: Day 1 and Day 8 after ICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: FANG WEN-FENG
role: PRINCIPAL_INVESTIGATOR
References: