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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040290
Receipt No. 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 2020/07/01

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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
Email 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
Email be.rann1988jp@gmail.com

Sponsor
Institute Department of Emergency and Critical Care Medicine, Hitachi General Hospital
Institute
Department

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
Email 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 Open public recruiting
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
2020 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045970

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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