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

September 24, 2023 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day mortality
Time Frame: Day 7 after hospital admission
Status of survival or mortality at Day 7 during hospital stay
Day 7 after hospital admission
28-day mortality
Time Frame: Day 28 after hospital admission
Status of survival or mortality at Day 28 during hospital stay
Day 28 after hospital admission
90-day mortality
Time Frame: Day 90 after hospital admission
Status of survival or mortality at Day 90 during hospital stay
Day 90 after hospital admission
Change of white blood cell between day 1 and day 8
Time Frame: Day 1 and Day8 after ICU admission
assessing the change of white blood cell count between day 1 and day 8
Day 1 and Day8 after ICU admission
ICU mortality
Time Frame: The day discharged from ICU, "through study completion, an average of 1 year".
Status of survival or mortality at the time discharged from ICU
The day discharged from ICU, "through study completion, an average of 1 year".
Hospital mortality
Time Frame: The day discharged from hospital, "through study completion, an average of 1 year".
Status of survival or mortality at the time discharged from hospital
The day discharged from hospital, "through study completion, an average of 1 year".
ICU Days
Time Frame: During hospitalization, "through study completion, an average of 1 year".
length of ICU stay
During hospitalization, "through study completion, an average of 1 year".
Ventilation days
Time Frame: During hospitalization, "through study completion, an average of 1 year".
Total using days of mechanical ventilation
During hospitalization, "through study completion, an average of 1 year".
Change of percentage of body fat between day 1 and day 8
Time Frame: 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)
Day 1 and Day 8 after ICU admission
Change of total body water between day 1 and day 8
Time Frame: 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)
Day 1 and Day 8 after ICU admission
Change of soft lean mass between day 1 and day 8
Time Frame: 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)
Day 1 and Day 8 after ICU admission
Concentration of serum IL-6 change between day 1 and day 8
Time Frame: 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)
Day 1 and Day 8 after ICU admission
Concentration of serum BDNF change between day 1 and day 8
Time Frame: 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)
Day 1 and Day 8 after ICU admission
Concentration of serum IL-15 change between day 1 and day 8
Time Frame: 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)
Day 1 and Day 8 after ICU admission
Concentration of serum SPARC change between day 1 and day 8
Time Frame: 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)
Day 1 and Day 8 after ICU admission
Concentration of serum Irisin change between day 1 and day 8
Time Frame: 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)
Day 1 and Day 8 after ICU admission
Concentration of serum Myostatin change between day 1 and day 8
Time Frame: 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)
Day 1 and Day 8 after ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 24, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202102342B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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