UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055149 |
|---|---|
| Receipt number | R000063005 |
| Scientific Title | Development of an epidemiological survey database on the assessment of severity of illness and its outcome in patients admitted to intensive care units nationwide in Japan |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2024/08/02 21:34:26 |
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Basic information
Public title
Epidemiological survey of patients admitting Intensive Care Units in Japan
Acronym
Epidemiological survey of ICU patients
Scientific Title
Development of an epidemiological survey database on the assessment of severity of illness and its outcome in patients admitted to intensive care units nationwide in Japan
Scientific Title:Acronym
Development of epidemiological survey for ICU patients in Japan
Region
| Japan |
Condition
Condition
Patients who admitted to ICU
Classification by specialty
| Medicine in general | Surgery in general | Obstetrics and Gynecology |
| Pediatrics | Anesthesiology | Cardiovascular surgery |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to contribute to the health care system in the field of intensive care medicine by improving the quality of care through benchmarking among facilities, developing intensive care medicine through the use of collected data, and utilizing the data for policy support and specialist systems.
Basic objectives2
Others
Basic objectives -Others
epidemiological survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival rate
Key secondary outcomes
Treatment period, Ventilator days, Duration of ICU stay, Duration of hospital stay
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 who admitted into ICU
Key exclusion criteria
None
Target sample size
3000000
Research contact person
Name of lead principal investigator
| 1st name | Kent |
| Middle name | |
| Last name | Doi |
Organization
The University of Tokyo Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL
03-3815-5411
kentdoi@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Hashiba |
Organization
Hirosaki University Hospital
Division name
Intensive Care Unit
Zip code
036-8563
Address
53 Honmachi, Hirosaki, Aomori, Japan
TEL
0172-33-5111
Homepage URL
https://www.jipad.org
ehashiba@hirosaki-u.ac.jp
Sponsor or person
Institute
Japanese Society of Intensive Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Graduate School of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo, Tokyo, Japan
Tel
03-5841-3600
hy-ohrs@m.u-tokyo.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
徳島大学病院 (徳島県)
東京慈恵会医科大学附属病院 (東京都)
京都府立医科大学附属病院 (京都府)
京都府立医科大学附属病院 (京都府)
奈良県立医科大学附属病院 (奈良県)
名古屋大学医学部附属病院 (愛知県)
東京大学医学部附属病院 (東京都)
東京医科歯科大学病院 (東京都)
神戸大学医学部附属病院 (兵庫県)
浜松医科大学医学部附属病院 (静岡県)
自治医科大学附属さいたま医療センター (埼玉県)
聖マリアンナ医科大学病院 (神奈川県)
新潟大学医歯学総合病院 (新潟県)
奈良県立医科大学附属病院 (奈良県)
岐阜大学医学部附属病院 (岐阜県)
大阪医科薬科大学病院 (大阪府)
国立大学法人群馬大学医学部附属病院 (群馬県)
和歌山県立医科大学附属病院 (和歌山県)
秋田大学医学部附属病院 (秋田県)
大阪大学医学部附属病院 (大阪府)
慶應義塾大学病院 (東京都)
滋賀医科大学医学部附属病院 (滋賀県)
独立行政法人国立病院機構京都医療センター (京都府)
独立行政法人国立病院機構京都医療センター (京都府)
獨協医科大学病院 (栃木県)
大分大学医学部附属病院 (大分県)
他 現時点で参加施設は128施設であり今後も増加する見込み
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was initiated in 2011 and passed the Ethics Review Committee as an observational study in 2014. At that time, registration as a clinical study was not required for observational research, so we have submitted a new application for this study even though it is still in the middle of research.
Management information
Registered date
| 2024 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063005
