UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059089 |
|---|---|
| Receipt number | R000067473 |
| Scientific Title | Early rehabilitation of intensive care unit patients - a multinational prospective observational study on dosage and outcome |
| Date of disclosure of the study information | 2025/09/16 |
| Last modified on | 2025/09/15 15:32:27 |
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Basic information
Public title
Early rehabilitation of intensive care unit patients - a multinational prospective observational study on dosage and outcome
Acronym
ERUPT Study
Scientific Title
Early rehabilitation of intensive care unit patients - a multinational prospective observational study on dosage and outcome
Scientific Title:Acronym
ERUPT Study
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Critical ill patients
Classification by specialty
| Intensive care medicine | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. What is the association of mobilisation dosage (frequency, duration and level of mobilisation) on
outcomes of critically ill patients?
2. Is there an association of the prehospital status or invasive mechanical ventilation at ICU admission with
outcomes of critically ill patients?
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is physical function measured at ICU discharge using the Functional Status Score for the Intensive Care Unit (FSS-ICU), the total score ranges from 0-35
Key secondary outcomes
1. ICU Mobility Scale (IMS) at ICU discharge
2. ICU length of stay
3. Hospital length of stay
4. Clinical Frailty Scale (CFS) at ICU discharge and 90 days
5. ICU-, hospital and 90-day mortality
6. WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) at 90 days
7. Barthel Score at ICU discharge and 90 days
8. IMS at 90 days
9. FSS-ICU at 90 days
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
1. Adult ( >=18 years old) within 48 hours of ICU admission
2. Expected to stay > 24 hours in the ICU
Key exclusion criteria
Patients are excluded if, at the time of screening,
- they receive end-of-life care
- their treatment plans are still under discussion and/or not all team members are committed to full active treatment
- their functional status is unlikely to be obtainable
- or they have language barriers
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Yamauchi |
Organization
Steel Memorial Yawata Hospital
Division name
Department of Rehabilitation
Zip code
805-8508
Address
1-1-1, Harunomachi, Yahatahigashi-ku, Kitakyushu, Fukuoka
TEL
0936719318
vivakannta@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Yamauchi |
Organization
Steel Memorial Yawata Hospital
Division name
Department of Rehabilitation
Zip code
805-8508
Address
1-1-1, Harunomachi, Yahatahigashi-ku, Kitakyushu, Fukuoka
TEL
0936719318
Homepage URL
https://erupt-study.eu/
vivakannta@yahoo.co.jp
Sponsor or person
Institute
Japanese Society for Early Mobilization
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Japanese Society for Early Mobilization
Address
Plairel Building 201, 1-2-12 Kudan-kita, Chiyoda-ku, Tokyo 102-0073, Japan
Tel
03-3556-5585
jsea@rishou.org
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 09 | Month | 15 | Day |
Last modified on
| 2025 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067473
