UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051202 |
|---|---|
| Receipt number | R000058398 |
| Scientific Title | Ultrasound-based upper limb muscle thickness for screening low muscularity at the intensive care unit admission |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2023/08/21 09:52:07 |
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Basic information
Public title
Ultrasound-based upper limb muscle thickness for screening low muscularity at the intensive care unit admission
Acronym
Ultrasound-based upper limb muscle thickness for screening low muscularity at the intensive care unit admission
Scientific Title
Ultrasound-based upper limb muscle thickness for screening low muscularity at the intensive care unit admission
Scientific Title:Acronym
Ultrasound-based upper limb muscle thickness for screening low muscularity at the intensive care unit admission
Region
| Japan |
Condition
Condition
adults patients equal to or more than 18 years admitted to the ICU
Classification by specialty
| Medicine in general | Surgery in general | Emergency medicine |
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate wether ultrasound-based upper limb muscle thickness is useful for screening muscularity at the intensive care unit admission.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between ultrsound-based upper limb muscle thickness and whole body muscularity
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
adults more than or equal to 18 years admitted to ICU, those expected to stay in ICU for more than 5 days, those who underwent the ultrasound assessments of the upper limb muscle at the day of ICU admission.
Key exclusion criteria
primary neuromuscular disease, obstacles at the ultrasound measurement site.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Kobe University
Division name
Department of Disaster and Emergency Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki, Chuo-ward, Kobe, 650-0017, Japan
TEL
078-382-6521
nobuto_nakanishi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuto |
| Middle name | |
| Last name | Nakanishi |
Organization
Kobe University
Division name
Department of Disaster and Emergency Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki, Chuo-ward, Kobe, Hyogo
TEL
078-382-6521
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
Department of Disaster and Emergency Medicine, Kobe University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Tokushima University Hospital
Address
2-50-1 Kuramoto, Tokushima
Tel
088-631-3111
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://clinicalnutritionespen.com/article/S2405-4577(23)01193-2/fulltext
Publication of results
Published
Result
URL related to results and publications
https://clinicalnutritionespen.com/article/S2405-4577(23)01193-2/fulltext
Number of participants that the trial has enrolled
64
Results
Upper limb muscle thickness had the discriminative power to assess low muscularity at an area under the curve of 0.77, and the cutoff value (26.8 cm) had 84.6% sensitivity and 66.7% specificity
Results date posted
| 2023 | Year | 08 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 15 | Day |
Baseline Characteristics
The mean age was 70 years, and the mean body mass index was 23.3 kg/m2
Participant flow
Retrospective study which included patients with ultrasound based-upper limb muscle thicnkess measurement.
Adverse events
None
Outcome measures
Ultrasond based upper limb muscle thickness and CT based muscle mass assessment
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
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
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 12 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 13 | Day |
Other
Other related information
Retrospective analysis of prospectively observed data
Management information
Registered date
| 2023 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058398
