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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028876
Receipt No. R000031376
Scientific Title Risk of the incidence of delirium and the utility of antipsychotics for delirium in elderly patients after cardiac surgery
Date of disclosure of the study information 2017/09/01
Last modified on 2019/09/02

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Basic information
Public title Risk of the incidence of delirium and the utility of antipsychotics for delirium in elderly patients after cardiac surgery
Acronym Risk of the incidence of delirium and the utility of antipsychotics for delirium in elderly patients after cardiac surgery
Scientific Title Risk of the incidence of delirium and the utility of antipsychotics for delirium in elderly patients after cardiac surgery
Scientific Title:Acronym Risk of the incidence of delirium and the utility of antipsychotics for delirium in elderly patients after cardiac surgery
Region
Japan

Condition
Condition Eldery patients (more than 65 year-old) scheduled to undergo cardiac surgery
Classification by specialty
Vascular surgery Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the resk factors of the incidence of delirium after cardiac surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes The incidence of delirium after cardiac surgery
Improvement of DRS-R-98 score 7 days after the administration of antipsychotics
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Other
Interventions/Control_1 Neuropsychological analysis pre- and post cardicac surgery
Interventions/Control_2 Stratified randomization and 7 days administration of antipsychotics
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
65 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Eldery patients (more than 65 year-old) shcedelued to undergo cardiac surgery in Department of cardio vascular surgey, Kumamoto University Hospital
Key exclusion criteria People with severe dementia and visual and hearing disabilities
Target sample size 275

Research contact person
Name of lead principal investigator
1st name Mamoru
Middle name
Last name Hashimoto
Organization Faculty of Life Science, Kumamoto University
Division name Neuropsychiary
Zip code 860-8556
Address Honjo 1-1-1, Chuo-ku, Kumamoto-shi, Kumamoto, 860-8556
TEL 096-373-5184
Email m-hashi@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Hiroko
Middle name
Last name Sugawara
Organization Faculty of Life Science, Kumamoto University
Division name Neuropsychiary
Zip code 860-8556
Address Honjo 1-1-1, Chuo-ku, Kumamoto-shi, Kumamoto, 860-8556
TEL 096-373-5184
Homepage URL
Email hiroko-sugawara@umin.ac.jp

Sponsor
Institute Faculty of Life Science, Kumamoto University
Institute
Department

Funding Source
Organization Faculty of Life Science, Kumamoto University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Life Science, Kumamoto University
Address Honjo 1-1-1, Chuo-ku, Kumamoto-shi, Kumamoto, 860-8556
Tel 096-373-5657
Email ski-shien@jimu.kumamoto-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 熊本大学病院(熊本県)

Other administrative information
Date of disclosure of the study information
2017 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
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
2016 Year 08 Month 29 Day
Date of IRB
2016 Year 09 Month 06 Day
Anticipated trial start date
2016 Year 09 Month 06 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 29 Day
Last modified on
2019 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031376

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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