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

Primary Purpose

Sepsis

Status

Recruiting

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

early mobilization (physical therapy)

About this trial

This is an interventional supportive care trial for Sepsis focused on measuring sepsis, early mobilization, myokines, body composition

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kaohsiung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

non-PT group

Early-PT group

Delayed-PT

Arm Description

with no physical treatment intervention (group 1)

with physical treatment intervention started in ICU admission day 3 (group 2)

with physical treatment intervention started after ICU admission day 3 (group 3)

Outcomes

Primary Outcome Measures

ICU mortality

Status of survival or mortality at the time discharged from ICU

Hospital mortality

Status of survival or mortality at the time discharged from hospital

7-day mortality

Status of survival or mortality at Day 7 during hospital stay

28-day mortality

Status of survival or mortality at Day 28 during hospital stay

90-day mortality

Status of survival or mortality at Day 90 during hospital stay

ICU Days

length of ICU stay

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

Ventilation days

Total using days of mechanical ventilation

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)

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)

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)

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)

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)

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)

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)

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)

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT06061224

First Posted

September 5, 2023

Last Updated

September 24, 2023

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT06061224

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

Keywords

sepsis, early mobilization, myokines, body composition

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

non-PT group

Arm Type

No Intervention

Arm Description

with no physical treatment intervention (group 1)

Arm Title

Early-PT group

Arm Type

Experimental

Arm Description

with physical treatment intervention started in ICU admission day 3 (group 2)

Arm Title

Delayed-PT

Arm Type

Experimental

Arm Description

with physical treatment intervention started after ICU admission day 3 (group 3)

Intervention Type

Behavioral

Intervention Name(s)

early mobilization (physical therapy)

Intervention Description

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

Primary Outcome Measure Information:

Title

ICU mortality

Description

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".

Title

Hospital mortality

Description

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".

Title

7-day mortality

Description

Status of survival or mortality at Day 7 during hospital stay

Time Frame

Day 7 after hospital admission

Title

28-day mortality

Description

Status of survival or mortality at Day 28 during hospital stay

Time Frame

Day 28 after hospital admission

Title

90-day mortality

Description

Status of survival or mortality at Day 90 during hospital stay

Time Frame

Day 90 after hospital admission

Title

ICU Days

Description

length of ICU stay

Time Frame

During hospitalization, "through study completion, an average of 1 year".

Title

Change of white blood cell between day 1 and day 8

Description

assessing the change of white blood cell count between day 1 and day 8

Time Frame

Day 1 and Day8 after ICU admission

Title

Ventilation days

Description

Total using days of mechanical ventilation

Time Frame

During hospitalization, "through study completion, an average of 1 year".

Title

Change of percentage of body fat between day 1 and day 8

Description

assessing the change of percentage of body fat between day 1 and day 8 by noninvasively Bio-electrical Impedance Analysis (BIA)

Time Frame