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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044032
Receipt No. R000050280
Scientific Title Muscle mass assessments by ultrasound and computed tomography
Date of disclosure of the study information 2021/04/25
Last modified on 2021/04/25

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Basic information
Public title Muscle mass assessments by ultrasound and computed tomography
Acronym Muscle mass assessments by ultrasound and computed tomography
Scientific Title Muscle mass assessments by ultrasound and computed tomography
Scientific Title:Acronym Muscle mass assessments by ultrasound and computed tomography
Region
Japan

Condition
Condition Patients admitted in the ICU
Classification by specialty
Emergency medicine Intensive care medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The difference of muscle mass assessments between ultrasound and CT
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The correlation between ultrasound and CT muscle mass assessments
Key secondary outcomes

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 with computed tomography assessment of third lumber vertebra level within 2 days before and after the ICU admission.
Key exclusion criteria primary neuromuscular disease, obstacle at the ultrasound measurement site
Target sample size 89

Research contact person
Name of lead principal investigator
1st name Nobuto
Middle name
Last name Nakanishi
Organization Tokushima University Hospital
Division name Emergency and Critical Care Medicine
Zip code 770-8503
Address 2-50-1, Kuramoto, Tokushima
TEL 080-1601-0115
Email nobuto_nakanishi@yahoo.co.jp

Public contact
Name of contact person
1st name Nobuto
Middle name
Last name Nakanishi
Organization Tokushima University Hospital
Division name Emergency and Critical Care Medicine
Zip code 770-8503
Address 2-50-1, Kuramoto, Tokushima 770-8503, Japan
TEL 088-633-9347
Homepage URL
Email nobuto_nakanishi@yahoo.co.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization Tokushima University Hospital
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 Research center in Tokushima University Hospital
Address 2-50-1, Kuramoto, Tokushima, Tokushima
Tel 088-633-9294
Email nobuto_nakanishi@yahoo.co.jp

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 徳島大学病院

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 25 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 89
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 No longer recruiting
Date of protocol fixation
2016 Year 05 Month 01 Day
Date of IRB
2016 Year 05 Month 10 Day
Anticipated trial start date
2021 Year 02 Month 02 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective analysis of prospectively observed data

Management information
Registered date
2021 Year 04 Month 25 Day
Last modified on
2021 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050280

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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