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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032646
Receipt No. R000037225
Scientific Title Multicenter Prospective Observational Registry of Delirium
Date of disclosure of the study information 2018/05/19
Last modified on 2019/11/03

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Basic information
Public title Multicenter Prospective Observational Registry of Delirium
Acronym Delirium Registry
Scientific Title Multicenter Prospective Observational Registry of Delirium
Scientific Title:Acronym Delirium Registry
Region
Japan

Condition
Condition Delirium
Classification by specialty
Medicine in general Surgery in general Psychiatry
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate epidemiology of delirium in a variety of medical conditions
Basic objectives2 Others
Basic objectives -Others To investigate epidemiology of delirium in a variety of medical conditions
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate epidemiology of delirium in a variety of medical conditions
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
1 years-old <=
Age-upper limit
120 years-old >
Gender Male and Female
Key inclusion criteria Patients with delirium or those who has possibility to become delirium
Key exclusion criteria N/A
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Hara, MD, PhD
Organization Japan Society of Clinical Research
Division name Department of Clinical Investigation
Zip code
Address Kita-ku Umeda 1-11-1000 Osaka Ekimae 4th Bldg 10F Osaka, 530-0001 Japan
TEL 0661315495
Email hara@japanscr.org

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Hara, MD, PhD
Organization Japan Society of Clinical Research
Division name Department of Clinical Investigation
Zip code
Address Kita-ku Umeda 1-11-1000 Osaka Ekimae 4th Bldg 10F Osaka, 530-0001 Japan
TEL 0661315495
Homepage URL https://www.japanscr.org/
Email hara@japanscr.org

Sponsor
Institute Japan Society of Clinical Research
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2018 Year 05 Month 19 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
2017 Year 07 Month 27 Day
Date of IRB
2017 Year 07 Month 27 Day
Anticipated trial start date
2017 Year 11 Month 08 Day
Last follow-up date
2019 Year 11 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Primary endpoint: Incidence of Delirium
Secondary endpoint: Total mortality, duration of hospitalization, etc

Management information
Registered date
2018 Year 05 Month 19 Day
Last modified on
2019 Year 11 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037225

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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