UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041450 |
|---|---|
| Receipt number | R000047316 |
| Scientific Title | Epidemiological analysis and improvement of medical infrastructure for severe acute respiratory failure (SARI/ARDS) |
| Date of disclosure of the study information | 2020/08/20 |
| Last modified on | 2025/07/23 15:00:50 |
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Basic information
Public title
Epidemiological analysis and improvement of medical infrastructure for severe acute respiratory failure (SARI/ARDS)
Acronym
Epidemiological analysis of severe acute respiratory failure (SARI/ARDS)
Scientific Title
Epidemiological analysis and improvement of medical infrastructure for severe acute respiratory failure (SARI/ARDS)
Scientific Title:Acronym
Epidemiological analysis of severe acute respiratory failure (SARI/ARDS)
Region
| Japan |
Condition
Condition
severe acute respiratory failure (SARI/ARDS)
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to systematically collect and analyze clinical data on severe acute respiratory infection (SARI) and acute respiratory distress syndrome (ARDS) caused by all factors in Japan, not limited to emerging infectious diseases such as COVID-19, and to utilize the results for the safety and health of the public.
Basic objectives2
Others
Basic objectives -Others
Epidemiological survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival rate
Key secondary outcomes
Treatment period, Ventilator days, ECMO days, Duration of ICU stay, Duration of hospital stay, Occurrence of complications, Frequency and duration of adjunctive therapies
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 who have developed severe acute respiratory failure (SARI/ARDS) (no age restrictions)
Key exclusion criteria
None
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Shime |
Organization
Hiroshima University
Division name
Department of Emergency and Critical Care Medicine,Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5456
nshime@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Ohshimo |
Organization
Hiroshima University
Division name
Department of Emergency and Critical Care Medicine,Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-5456
Homepage URL
ohshimos@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
Tel
082-257-5907
iryo-seisaku@office.hiroshima-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 | 08 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2031 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2031 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 03 | Month | 31 | Day |
Other
Other related information
Data collecting
Management information
Registered date
| 2020 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047316
