UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039754 |
|---|---|
| Receipt number | R000045339 |
| Scientific Title | Muscle mass and outcomes of critically ill patients |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2024/03/12 10:20:09 |
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Basic information
Public title
Muscle mass and outcomes of critically ill patients
Acronym
Muscle mass and outcomes of critically ill patients
Scientific Title
Muscle mass and outcomes of critically ill patients
Scientific Title:Acronym
Muscle mass and outcomes of critically ill patients
Region
| Japan |
Condition
Condition
Patients admitted in the ICU
Classification by specialty
| Medicine in general | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the influence of muscle mass to outcomes in patients admitted in the ICU.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality (ICU, Hospital)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted in the ICU
Key exclusion criteria
Insufficient information about body wight and height
Target sample size
50000
Research contact person
Name of lead principal investigator
| 1st name | Nobuto |
| Middle name | Nakanishi |
| Last name | Nakanishi |
Organization
The university of Tokushima
Division name
Emergency and critical care medicine
Zip code
770-8503
Address
2-50-1 Kuramoto Tokushima
TEL
0886339347
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
2-50-1 Kuramoto Tokushima
Zip code
770-8503
Address
Tokushima
TEL
0886339347
Homepage URL
nobuto_nakanishi@yahoo.co.jp
Sponsor or person
Institute
The university of Tokushima, emergency and critical care medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Clinical Trial Center for Developmental therapeutics, Tokushima University Hospital
Address
2-50-1 Kuramoto Tokushima
Tel
0886339347
awachiken@tokushima-u.ac.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
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2079-9721/12/2/30
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2079-9721/12/2/30
Number of participants that the trial has enrolled
3916
Results
Regarding BMI, in-hospital mortality was 36.9%, 29.8%, 26.7%, and 27.9% in patients who were underweight, normal weight, overweight, and obese, respectively (p < 0.01).
Results date posted
| 2024 | Year | 03 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 16 | Day |
Baseline Characteristics
The inclusion criteria were age more than or equal to 18 years and a diagnosis of sepsis or septic shock.
Participant flow
Retrospective study in patients admitted in the intensive care unit
Adverse events
None
Outcome measures
BMI and calculated lean body mass
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 03 | Month | 10 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045339
| 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 |
