UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028876
Receipt number 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 2021/11/17 15:31:46

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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 or person

Institute

Faculty of Life Science, Kumamoto University

Institute

Department

Personal name



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

Value
https://center6.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