NCT06061224

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable sepsis

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

September 29, 2023

Status Verified

August 1, 2023

Enrollment Period

3.5 years

First QC Date

September 5, 2023

Last Update Submit

September 24, 2023

Conditions

Sepsis

Keywords

sepsisearly mobilizationmyokinesbody composition

Outcome Measures

Primary Outcomes (17)

  • 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".

  • 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".

  • 7-day mortality

    Status of survival or mortality at Day 7 during hospital stay

    Day 7 after hospital admission

  • 28-day mortality

    Status of survival or mortality at Day 28 during hospital stay

    Day 28 after hospital admission

  • 90-day mortality

    Status of survival or mortality at Day 90 during hospital stay

    Day 90 after hospital admission

  • ICU Days

    length of ICU stay

    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

    Day 1 and Day8 after ICU admission

  • Ventilation days

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Study Arms (3)

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)

Behavioral: early mobilization (physical therapy)

Delayed-PT

EXPERIMENTAL

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

Behavioral: early mobilization (physical therapy)

Interventions

early mobilization (physical therapy)BEHAVIORAL

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

Delayed-PTEarly-PT group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Aadmission in ICU 2. Clinical diagnosis of sepsis

You may not qualify if:

  • \. Expired in 3-days 2. Cardiac stents or pacemakers 3. Airborne disease 4. Contact-transmitted disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

MeSH Terms

Conditions

Sepsis

Interventions

Early AmbulationPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • FANG WEN-FENG

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

FANG WEN-FENG

CONTACT

+886 7 731 7123wenfengfang@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 29, 2023

Study Start

January 1, 2022

Primary Completion

June 30, 2025

Study Completion

September 30, 2025

Last Updated

September 29, 2023

Record last verified: 2023-08

Locations

TW(1)