UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044747 |
|---|---|
| Receipt number | R000051104 |
| Scientific Title | Muscle assessment with ultrasound and N-titin for critical illness myopathy |
| Date of disclosure of the study information | 2021/07/03 |
| Last modified on | 2023/04/26 15:05:09 |
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Basic information
Public title
Muscle assessment with ultrasound and N-titin for critical illness myopathy
Acronym
MUSCLE study
Scientific Title
Muscle assessment with ultrasound and N-titin for critical illness myopathy
Scientific Title:Acronym
MUSCLE study
Region
| Japan |
Condition
Condition
critical illness myopathy
Classification by specialty
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation between ultrasound-imaged muscle brightness pattern and various endpoints of muscle injuries leading to muscle mass loss and physical function decline in critically ill patients, and to assess its effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ICU-AW
Key secondary outcomes
N-titin, FSS-ICU, Barthel Index, EQ-5d-5l, IES-R, survival rate, duration of mechanical ventilation, length of ICU stay, length of hospital stay
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients 18 years of age or older admitted to the intensive care unit.
Patients expected to be hospitalized in ICU for more than 48 hours.
Key exclusion criteria
Patients with anuria.
Patients with thigh trauma or infection that makes muscle mass measurement difficult.
Patients using ECMO.
Patients admitted to ICU for the second or later time in the same hospitalization.
Target sample size
100
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
317-0077
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
317-0077
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
ZENKYOREN (National Mutual Insurance Federation of Agricultural Cooperatives)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Corporate Hospital Group, Hitachi, Ltd.
Address
2-1-1, Jonancho, Hitachi, Ibaraki, Japan
Tel
0294231111
masahiro.miura.cz@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
| 2021 | Year | 07 | Month | 03 | 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
| 2021 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Research Design)
Cohort study
(Patients)
All patients who entered our ICU between July 5, 2021 and March 31, 2022 and managed by our department, and met the selection criteria.
Management information
Registered date
| 2021 | Year | 07 | Month | 03 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051104
