UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029349 |
|---|---|
| Receipt number | 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 18:11:28 |
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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
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
mamashockpapashock@yahoo.co.jp
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033541
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
