UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058771 |
|---|---|
| Receipt number | R000067201 |
| Scientific Title | Evaluation of Quality of Care in Intensive Care Units Using the Japanese ICU Patient Database and DPC Data |
| Date of disclosure of the study information | 2025/08/12 |
| Last modified on | 2025/08/12 15:40:04 |
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Basic information
Public title
Evaluation of Quality of Care in Intensive Care Units Using the Japanese ICU Patient Database and DPC Data
Acronym
Evaluation of Quality of Care Using ICU Patient Database and DPC Data
Scientific Title
Evaluation of Quality of Care in Intensive Care Units Using the Japanese ICU Patient Database and DPC Data
Scientific Title:Acronym
Evaluation of Quality of Care Using ICU Patient Database and DPC Data
Region
| Japan |
Condition
Condition
All patients admitted to the ICUs of our hospital and collaborating institutions
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will collect data from multiple institutions, including the Japanese Intensive Care Patient Database (JIPAD) and DPC data (information on medical practices during ICU stays), to construct a comprehensive database. Furthermore, the results will be benchmarked to standardize performance evaluation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival rate, ICU length of stay, duration of mechanical ventilation, etc.
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
All patients admitted to the ICUs of our hospital and collaborating institutions will be included.
Key exclusion criteria
Patients who request exclusion through the opt-out process at each institution will be excluded.
Target sample size
670000
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Shime |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Division name
Department of Emergency and Critical Care Medicine
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
Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan
Division name
Department of Emergency and Critical Care Medicine
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
082-257-5456
ohshimos@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
| 2025 | Year | 08 | Month | 12 | 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
| 2025 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2036 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection in progress
Management information
Registered date
| 2025 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067201
