UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040290 |
|---|---|
| Receipt number | R000045970 |
| Scientific Title | Efficacy of Intensive goal-directed rehabilitation with electric muscle stimulation and nutrition (I-GREEN) protocol in intensive care unit |
| Date of disclosure of the study information | 2020/05/07 |
| Last modified on | 2021/09/26 10:36:42 |
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Basic information
Public title
Efficacy of Intensive goal-directed rehabilitation with electric muscle stimulation and nutrition (I-GREEN) protocol in intensive care unit
Acronym
Efficacy of Intensive goal-directed rehabilitation with electric muscle stimulation and nutrition (I-GREEN) protocol in intensive care unit
Scientific Title
Efficacy of Intensive goal-directed rehabilitation with electric muscle stimulation and nutrition (I-GREEN) protocol in intensive care unit
Scientific Title:Acronym
Efficacy of Intensive goal-directed rehabilitation with electric muscle stimulation and nutrition (I-GREEN) protocol in intensive care unit
Region
| Japan |
Condition
Condition
Patients admitted to ICU
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacies of the protocol that links nutrition and rehabilitation on PICS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
femoral muscle volume change from day 1 through 10
Key secondary outcomes
MRC score, FSS-ICU, EQ-5d at ICU discharge
Barthel Index at hospital discharge
Target nutrition achievement rate
N-titin level of days 1,3,5 and 7
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Rehabilitation, including electrical stimulation of the lower extremities, and nutrition administration in accordance with IMS was performed during the ICU admission according to the protocol.
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
ICU admission patients over 18 years old
Patients expected to be hospitalized for 10 days or longer
Patients who have obtained consent from the person or a representative
Key exclusion criteria
Pregnant women
women who can get pregnant
Patients with anuria
Patients who have difficulty measuring thigh muscle mass after trauma, amputation or infection
ECMO patients
Other patients who are determined to be inappropriate as subjects by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | Nakano |
Organization
Hitachi General Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
3170077
Address
2-1-1, Jonancho, Hitachi, Ibaraki, Japan
TEL
0294231111
be.rann1988jp@gmail.com
Public contact
Name of contact person
| 1st name | Hidehiko |
| Middle name | |
| Last name | Nakano |
Organization
Hitachi General Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
3170077
Address
2-1-1, Jonancho, Hitachi, Ibaraki, Japan
TEL
0294231111
Homepage URL
be.rann1988jp@gmail.com
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Hitachi General Hospital
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
Hitachi General Hospital Institutional Review Board
Address
2-1-1, Jonancho, Hitachi, Ibaraki, Japan
Tel
0294-23-1111
hitachi.chiken.ha@hitachi.com
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
| 2020 | Year | 05 | Month | 07 | 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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 02 | Day |
Last modified on
| 2021 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045970
