UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037834 |
|---|---|
| Receipt number | R000043115 |
| Scientific Title | Current status of assessment tools on delirium in the Japanese intensive care unit; a prospective multicenter observational survey |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2024/03/01 11:44:52 |
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Basic information
Public title
Current status of assessment tools on delirium in the Japanese intensive care unit; a prospective multicenter observational survey
Acronym
Survey of delirium assessment
Scientific Title
Current status of assessment tools on delirium in the Japanese intensive care unit; a prospective multicenter observational survey
Scientific Title:Acronym
Survey of delirium assessment
Region
| Japan |
Condition
Condition
Critically ill patients
Classification by specialty
| Psychiatry | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the situation of usage of the delirium assessment tools in the intensive care unit
Basic objectives2
Others
Basic objectives -Others
To investigate the:
Usage of the delirium evaluation method
Implementation rate of delirium evaluation for patients entering department of intensive care (ICU / HCU, etc.)
The incidence of delirium, and its association with evaluation method and risk factors for delirium
Delirium at ICU discharge
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of delirium assessed by the assessment tool used by each institution
Key secondary outcomes
Usage rate of delirium evaluation method by institutions
Comparison of the incidence of delirium between delirium assessment tools
The incidence of delirium in postoperative patients
Delirium prevalence when discharge from department of intensive care
Relationship between risk factors for delirium and the occurrence of delirium
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 admit to, and discharge from department of intensive care within study period (one month)
Key exclusion criteria
Exclude patients who announce they will not participate in the study
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Morimatsu |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Anesthesiology and Resuscitology
Zip code
700-8558
Address
2-5-1 Shikatacho, Kitaku, Okayama, Japan
TEL
086-235-7327
pb9b45wr@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenzo |
| Middle name | |
| Last name | Ishii |
Organization
Fukuyama City Hospital
Division name
Department of Anesthesiology
Zip code
721-8511
Address
5-23-1 Zao-cho, Fukuyama, Hiroshima
TEL
094-941-5151
Homepage URL
keishii1101@gmail.com
Sponsor or person
Institute
Department of Anesthesiology and Resuscitology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences,
Department of Anesthesiology and Resuscitology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
Kita-ku, Shikata-cho 2-5-1, Okayama
Tel
086-235-6610
mae6605@adm.okayama-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
岡山大学病院（岡山県）
岡山医療センター（岡山県）
岡山協立病院（岡山県）
岡山旭東病院（岡山県）
岡山市立市民病院（岡山県）
岡山赤十字病院（岡山県）
尾道市立市民病院（広島県）
香川県立中央病院（香川県）
香川労災病院 麻酔科（香川県）
川崎医科大学総合医療センター（岡山県）
川崎医科大学附属病院（岡山県）
国立がん研究センター中央病院（東京都）
済生会今治病院（愛媛県）
高砂市民病院（兵庫県）
近森病院（高知県）
津山中央病院（岡山県）
姫路聖マリア病院（兵庫県）
姫路赤十字病院（兵庫県）
広島市民病院（広島県）
福山市民病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 01 | 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
1210
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Now analyzing
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
| 2019 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 29 | Day |
Date analysis concluded
Other
Other related information
Multi-center prospective observational study
Management information
Registered date
| 2019 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043115
| 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 |
