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

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06061224
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 44.9
• Patients Per Site Per Month: 13.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Behavioral: early mobilization (physical therapy)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Influences of Duration and Intensity of Early Mobilization on Myokines, Body Composition and Outcomes of Septic Patients in Intensive Care Unit
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Jun 30, 2025
• Anticipated Study Completion Date: Sep 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: non-PT group with no physical treatment intervention (group 1)
Experimental: Early-PT group with physical treatment intervention started in ICU admission day 3 (group 2)	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
Experimental: Delayed-PT with physical treatment intervention started after ICU admission day 3 (group 3)	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

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 7-day mortality [Day 7 after hospital admission]

   Status of survival or mortality at Day 7 during hospital stay

4. 28-day mortality [Day 28 after hospital admission]

   Status of survival or mortality at Day 28 during hospital stay

5. 90-day mortality [Day 90 after hospital admission]

   Status of survival or mortality at Day 90 during hospital stay

6. ICU Days [During hospitalization, "through study completion, an average of 1 year".]

   length of ICU stay

7. 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

8. Ventilation days [During hospitalization, "through study completion, an average of 1 year".]

   Total using days of mechanical ventilation

9. 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)

10. 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)

11. 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)

12. 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)

13. 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)

14. 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)

15. 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)

16. 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)

17. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung City		Taiwan	83301

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

• Principal Investigator: FANG WEN-FENG, Chang Gung Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT06061224
• Other Study ID Numbers: 202102342B0
• First Posted: Sep 29, 2023
• Last Update Posted: Sep 29, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chang Gung Memorial Hospital: sepsis; early mobilization; myokines; body composition
• Additional relevant MeSH terms: Sepsis

Study Results

No Results Posted as of Sep 29, 2023