SepsisNCT06061224
The Influences of Early Mobilization on Myokines, Body Composition and Outcomes in ICU Septic Patients
A study testing early mobilization (physical therapy) in people with Sepsis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis
- What is being tested?
- early mobilization (physical therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aadmission in ICU 2. Clinical diagnosis of sepsis
Who cannot join
- 1. Expired in 3-days 2. Cardiac stents or pacemakers 3. Airborne disease 4. Contact-transmitted disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
WEN-FENG Fang, +886 7 731 7123 ext. 8775, wenfengfang@yahoo.com.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- early mobilization (physical therapy)
- Keywords
- sepsis, early mobilization, myokines, body composition
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early mobilization (physical therapy)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| non-PT group | No intervention | with no physical treatment intervention (group 1) |
| Early-PT group | Experimental | with physical treatment intervention started in ICU admission day 3 (group 2) Receives: Behavioral: early mobilization (physical therapy) |
| Delayed-PT | Experimental | with physical treatment intervention started after ICU admission day 3 (group 3) Receives: Behavioral: early mobilization (physical therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Status of survival or mortality at the time discharged from ICU
Measured: The day discharged from ICU, "through study completion, an average of 1 year".
Hospital mortality
Status of survival or mortality at the time discharged from hospital
Measured: The day discharged from hospital, "through study completion, an average of 1 year".
7-day mortality
Status of survival or mortality at Day 7 during hospital stay
Measured: Day 7 after hospital admission
28-day mortality
Status of survival or mortality at Day 28 during hospital stay
Measured: Day 28 after hospital admission
90-day mortality
Status of survival or mortality at Day 90 during hospital stay
Measured: Day 90 after hospital admission
ICU Days
length of ICU stay
Measured: During hospitalization, "through study completion, an average of 1 year".
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
Measured: Day 1 and Day8 after ICU admission
Ventilation days
Total using days of mechanical ventilation
Measured: During hospitalization, "through study completion, an average of 1 year".
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)
Measured: Day 1 and Day 8 after ICU admission
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)
Measured: Day 1 and Day 8 after ICU admission
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)
Measured: Day 1 and Day 8 after ICU admission
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)
Measured: Day 1 and Day 8 after ICU admission
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)
Measured: Day 1 and Day 8 after ICU admission
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)
Measured: Day 1 and Day 8 after ICU admission
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)
Measured: Day 1 and Day 8 after ICU admission
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)
Measured: Day 1 and Day 8 after ICU admission
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)
Measured: Day 1 and Day 8 after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Jan 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FANG WEN-FENG, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061224
- Sponsor's protocol ID
- 202102342B0
- Status last verified
- Aug 2023
- First submitted
- 5 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influences of Duration and Intensity of Early Mobilization on Myokines, Body Composition and Outcomes of Septic Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06061224
- Acronym / sponsor ID
- 202102342B0
- Conditions
- Sepsis
- Keywords
- sepsis, early mobilization, myokines, body composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-PT group | No intervention | –with no physical treatment intervention (group 1) |
| Early-PT group | Experimental | Behavioral: early mobilization (physical therapy)with physical treatment intervention started in ICU admission day 3 (group 2) |
| Delayed-PT | Experimental | Behavioral: early mobilization (physical therapy)with physical treatment intervention started after ICU admission day 3 (group 3) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Aadmission in ICU 2. Clinical diagnosis of sepsis
Key exclusion criteria (1 listed)
- 1. Expired in 3-days 2. Cardiac stents or pacemakers 3. Airborne disease 4. Contact-transmitted disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Delayed-PT, Early-PT group |
Primary outcome
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
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
7-day mortality
Time frame: Day 7 after hospital admission
Status of survival or mortality at Day 7 during hospital stay
28-day mortality
Time frame: Day 28 after hospital admission
Status of survival or mortality at Day 28 during hospital stay
90-day mortality
Time frame: Day 90 after hospital admission
Status of survival or mortality at Day 90 during hospital stay
ICU Days
Time frame: During hospitalization, "through study completion, an average of 1 year".
length of ICU stay
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
Ventilation days
Time frame: During hospitalization, "through study completion, an average of 1 year".
Total using days of mechanical ventilation
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
FANG WEN-FENG principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early mobilization (physical therapy) in people with Sepsis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FANG WEN-FENG (+886 7 731 7123 ext. 8775, wenfengfang@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: The day discharged from ICU, "through study completion, an average of 1 year".). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.