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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029349
Receipt No. R000033541
Scientific Title The study of muscle amounts change in critical care by intervention of nutrition and rehabilitation.
Date of disclosure of the study information 2017/09/29
Last modified on 2018/08/16

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Basic information
Public title The study of muscle amounts change in critical care by intervention of nutrition and rehabilitation.
Acronym The study of ICU acquired weakness
Scientific Title The study of muscle amounts change in critical care by intervention of nutrition and rehabilitation.
Scientific Title:Acronym The study of ICU acquired weakness
Region
Japan

Condition
Condition critically ill
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether specific nutritions and rehabilitations can reduce muscle myopathy as ICU acquired weakness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of femoral muscle amounts by CT evaluation before to after intensive care
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Food Device,equipment
Interventions/Control_1 Given traditional rehabilitation
Interventions/Control_2 Given traditional rehabilitation and electrical muscle stimulation for 10 days.
Interventions/Control_3 Given traditional rehabilitation, electrical muscle stimulation and traditional nutrition.
Interventions/Control_4 Given traditional rehabilitation, electrical muscle stimulation, traditional nutrition and HMB for 10 days.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who are admitted to intensive care units in emergency and critical care center of Hitachi General Hospital
Key exclusion criteria Age<20, female and age <35, femoral events such as amputation, taruma, infection. Consent can not be gotten.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kensuke Nakamura
Organization Hitachi General Hospital
Division name Department of Emergency and Critical Care Medicine
Zip code
Address Hitachi General Hospital, 2-1-1, Jonantyo, Hitachi, Ibaraki, 317-0077, Japan
TEL 0294231111
Email mamashockpapashock@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kensuke Nakamura
Organization Hitachi General Hospital
Division name Department of Emergency and Critical Care Medicine
Zip code
Address Hitachi General Hospital, 2-1-1, Jonantyo, Hitachi, Ibaraki, 317-0077, Japan
TEL 0294231111
Homepage URL
Email mamashockpapashock@yahoo.co.jp

Sponsor
Institute Hitachi General Hospital
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 09 Month 29 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
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 29 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033541

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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