UMIN-CTR Clinical Trial

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	Completed
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	2021 Year 11 Month 17 Day

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