UMIN-CTR Clinical Trial

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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