UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040754 |
|---|---|
| Receipt number | R000046531 |
| Scientific Title | Examination of early rehabilitation effect in an emergency center and intensive care unit in patients with sepsis: A Prospective Multicenter Cohort Study |
| Date of disclosure of the study information | 2020/06/14 |
| Last modified on | 2026/06/19 20:31:37 |
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Basic information
Public title
Examination of early rehabilitation effect in an emergency center and intensive care unit in patients with sepsis: A Prospective Multicenter Cohort Study
Acronym
Examination of early rehabilitation effect in patients with sepsis: A Prospective Multicenter Cohort Study
Scientific Title
Examination of early rehabilitation effect in an emergency center and intensive care unit in patients with sepsis: A Prospective Multicenter Cohort Study
Scientific Title:Acronym
Examination of early rehabilitation effect in patients with sepsis: A Prospective Multicenter Cohort Study
Region
| Japan |
Condition
Condition
Sepsis
Septic shock
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of early rehabilitation in patients with sepsis by a multicenter study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADL using the Barthel index. Barthel index (BI) is evaluated by physical therapist at discharge from hospital.
Key secondary outcomes
Onset of pulmonary complications and delirium, length of hospital stay, cost-effectiveness, discharge outcome.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects of this study were sepsis patients who entered the emergency center and intensive care unit between April 2020 and September 2023.
Key exclusion criteria
Patients with head injuries, burns, spinal injuries, lower limbs with multiple fractures, and those with septic shock who are unresponsive to maximal treatment, moribund or had an expect mortality within 48 h.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Yasunari |
| Middle name | |
| Last name | Sakai |
Organization
Shinshu University Hospital
Division name
Rehabilitation
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto-shi, Nagano
TEL
0263-37-2836
yasunari_sakai1028@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasunari |
| Middle name | |
| Last name | Sakai |
Organization
Shinshu University Hospital
Division name
Rehabilitation
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto-shi, Nagano
TEL
0263-37-2836
Homepage URL
yasunari_sakai1028@yahoo.co.jp
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shinshu University.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Aizawa Hospital
Ina Central Hospital
Saku Central Hospital Advanced Care Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
3-1-1 Asahi, Matsumoto-shi, Nagano
Tel
0263-37-2572
mdrinri@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
信州大学医学部附属病院（長野県）
社会医療法人財団 相澤病院（長野県）
伊那中央病院（長野県）
JA長野厚生連 佐久医療センター（長野県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000046531
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40869728/
Number of participants that the trial has enrolled
253
Results
This study showed that dedicated physical therapists accelerated rehabilitation initiation in sepsis patients, reduced respiratory complications, and improved ADL recovery. In the multicenter EROSSCS study, early rehabilitation (<=3 days) reduced ICU-AW incidence, while dedicated staffing alone had no effect.
Results date posted
| 2026 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
During the study period, a total of 253 sepsis patients were enrolled in the four centers.From those, 99 patients fulfilled the exclusion criteria and 154 met the inclusion criteria.
Seventy-six patients (49.4%) were diagnosed with ICU-AW at ICU and emergency center discharged, and 78 patients were not. Baseline characteristics of patients with and without ICU-AW are shown in Table 1. Importantly, no adverse events related to mobilization were observed in this study.Patients with ICU-AW demonstrated higher use of anticoagulants at baseline (p < 0.05). These patients also had a significantly slower start of mobilization and a lower BI (p < 0.05). Finally, the breakdown of the source of infection in ICU-AW patients was 31% urinary tract, 18% respiratory tract, 18% gastroenteritis, 9% abdominal, and 24% other, with urinary tract being the most common.
Participant flow
All patients received routine therapy and management according to the standard protocols of the ICU and emergency departments, including vital signs monitoring, tube and ventilator management, position management, nutritional support, and other symptomatic and supportive treatments. In addition, early mobilization was implemented as part of routine clinical practice. Before each mobilization session, patient tolerance and risk were assessed. Based on the patient's disease type, level of consciousness, and muscle strength, the primary care physician and physical therapist or early mobilization team determined whether to initiate passive mobilization or active exercise. During the out-of-bed phase, active exercises, including standing, sitting, gait training, and ambulation, were performed with assistance. The frequency and intensity of exercise were adjusted according to the patient's condition. Additionally, pulmonary rehabilitation (including deep breathing exercises, periodic noninvasive ventilation support, and assisted coughing), electrical muscle stimulation using a general therapeutic electrical stimulator, and other mobilization techniques were incorporated as needed. If necessary, a bed with a tilt function was used to facilitate early mobilization. Mobilization sessions were conducted once or twice daily, with each session lasting 20-40 min, and continued until hospital discharge.
[Implementation Criteria]
Early mobilization was performed in accordance with the discontinuation criteria outlined in the Japanese Clinical Practice Guidelines for Rehabilitation in Critically Ill Patients (2023). If abnormal vital signs or other high-risk conditions (including persistent elevated intracranial pressure, acute myocardial ischemia, gastrointestinal bleeding, etc.) occurred, the intervention was suspended. The suspended intervention was gradually resumed once the patient's condition stabilized.
Adverse events
No adverse events related to this study were observed.
Outcome measures
Patients with ICU-AW demonstrated lower BI, SPPB total at discharge, and discharge to home rate (p < 0.05). These patients also had a significantly higher incidence of pulmonary
complications during hospitalization (p < 0.05).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participant age, sex, body mass index (BMI), sequential organ failure assessment (SOFA) score, systemic inflammatory response syndrome (SIRS) score, disseminated intravascular coagulation (DIC) score, laboratory data (procalcitonin), primary source of infection, use of therapeutic medication, use of mechanical ventilation, BI baseline and discharge, length of hospital stay, patients discharge outcome, cost-effectiveand, onset of plmonary complications and delirium, the number of days until rehabilitation are recorded.
Management information
Registered date
| 2020 | Year | 06 | Month | 13 | Day |
Last modified on
| 2026 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046531
