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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021971
Receipt No. 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

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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
Email 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
Email 0724.psyc@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University, Medical Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025327

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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