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

Sepsis Clinical Trial

Official title:

The Influences of Duration and Intensity of Early Mobilization on Myokines, Body Composition and Outcomes of Septic Patients in Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06061224
• Other study ID #: 202102342B0
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: August 2023
• Source: Chang Gung Memorial Hospital
• Contact: FANG WEN-FENG
• Phone: +886 7 731 7123
• Email: wenfengfang[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis

Intervention

Behavioral:
• early mobilization (physical therapy)
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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU mortality	Status of survival or mortality at the time discharged from ICU	The day discharged from ICU, "through study completion, an average of 1 year".
Primary	Hospital mortality	Status of survival or mortality at the time discharged from hospital	The day discharged from hospital, "through study completion, an average of 1 year".
Primary	7-day mortality	Status of survival or mortality at Day 7 during hospital stay	Day 7 after hospital admission
Primary	28-day mortality	Status of survival or mortality at Day 28 during hospital stay	Day 28 after hospital admission
Primary	90-day mortality	Status of survival or mortality at Day 90 during hospital stay	Day 90 after hospital admission
Primary	ICU Days	length of ICU stay	During hospitalization, "through study completion, an average of 1 year".
Primary	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	Day 1 and Day8 after ICU admission
Primary	Ventilation days	Total using days of mechanical ventilation	During hospitalization, "through study completion, an average of 1 year".
Primary	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)	Day 1 and Day 8 after ICU admission
Primary	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)	Day 1 and Day 8 after ICU admission
Primary	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)	Day 1 and Day 8 after ICU admission
Primary	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)	Day 1 and Day 8 after ICU admission
Primary	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)	Day 1 and Day 8 after ICU admission
Primary	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)	Day 1 and Day 8 after ICU admission
Primary	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)	Day 1 and Day 8 after ICU admission
Primary	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)	Day 1 and Day 8 after ICU admission
Primary	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)	Day 1 and Day 8 after ICU admission