UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021971 |
|---|---|
| Receipt number | R000025327 |
| Scientific Title | A clinical study on prospective factors of postoperative delirium |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2019/04/22 10:02:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A clinical study on prospective factors of postoperative delirium
Acronym
A study on prospective factors of delirium
Scientific Title
A clinical study on prospective factors of postoperative delirium
Scientific Title:Acronym
A study on prospective factors of delirium
Region
| Japan |
Condition
Condition
postoperative delirium
Classification by specialty
| Vascular surgery | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to find out some prospective factors of postoperative factors among the pre-.para- and post-operative medical information. A detailed examination will be carried out on imaging data of brain MRI obtained before the operation.
Basic objectives2
Others
Basic objectives -Others
To obtain a suggestive insight on the pathophysiology of delirium.
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
prospective factors of postoperative delirium
Key secondary outcomes
progressive factors of postoperative 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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients will be underwent by elective cardiovascular operations
Key exclusion criteria
patients with neuropsychiatric disorders, such as dementia and schizophrenia
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Akeo |
| Middle name | |
| Last name | Kurumaji |
Organization
Tokyo Medical and Dental University
Division name
graduate school, section of psychiatry and behavioral sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5242
0724.psyc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Akeo |
| Middle name | |
| Last name | Kurumaji |
Organization
Tokyo Medical and Dental University
Division name
graduate school, section of psychiatry and behavioral sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5242
Homepage URL
0724.psyc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University, Medical Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Science Research of Japan Society for The Promotion of Science.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Tokyo Medical and Dental Univeisity
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo,
Tel
0.-3813-6111
info.bec@tmd.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
東京医科歯科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 04 | Month | 18 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025327
