The Influences of Early Mobilization on Myokines, Body Composition and Outcomes in ICU Septic Patients

Not Applicable

Recruiting

• Conditions: Sepsis
• Interventions: Behavioral: early mobilization (physical therapy)

• Registration Number: NCT06061224
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-08
• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-24
• Last Update Submitted: 2023-09-24
• Study First Posted: 2023-09-29
• Last Update Posted: 2023-09-29
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early-PT group	early mobilization (physical therapy)	with physical treatment intervention started in ICU admission day 3 (group 2)
Delayed-PT	early mobilization (physical therapy)	with physical treatment intervention started after ICU admission day 3 (group 3)

Primary Outcome Measures

Name	Time	Method
ICU Days	During hospitalization, "through study completion, an average of 1 year".	length of ICU stay
Hospital mortality	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	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	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)
28-day mortality	Day 28 after hospital admission	Status of survival or mortality at Day 28 during hospital stay
7-day mortality	Day 7 after hospital admission	Status of survival or mortality at Day 7 during hospital stay
90-day mortality	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	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	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	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	The day discharged from ICU, "through study completion, an average of 1 year".	Status of survival or mortality at the time discharged from ICU
Change of white blood cell between day 1 and day 8	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	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	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	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	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	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)

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan