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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030096
Receipt No. R000034358
Scientific Title The relationship between Type D personality and delirium after cardiac surgery
Date of disclosure of the study information 2017/11/23
Last modified on 2017/11/23

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Basic information
Public title The relationship between Type D personality and delirium after cardiac surgery
Acronym The relationship between Type D personality and delirium after cardiac surgery
Scientific Title The relationship between Type D personality and delirium after cardiac surgery
Scientific Title:Acronym The relationship between Type D personality and delirium after cardiac surgery
Region
Japan

Condition
Condition Enrollment criteria included patients aged over 18 years, undergoing scheduled cardiovascular patients.
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The present study is reveal the asociation between type D character and the development of postoperative delirium after cardiac surgery.
Basic objectives2 Others
Basic objectives -Others relationship
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Delirium coma free days.
Key secondary outcomes Prevalence of 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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Enrollment criteria included patients aged over 18 years, undergoing scheduled cardiovascular, thoracic and abdominal artery operations between October 2015 and August 2016.
Key exclusion criteria Patients were excluded if they had stroke, were deaf or otherwise unable to speak, or had current or previous major depression.
Target sample size 142

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki inoue
Organization University of Tsukuba
Division name Department of Emergency and Critical Care Medicine, Faculty of Medicine
Zip code
Address 1-1-1 Tennoudai, Tsukuba-shi, Ibaraki, Japan
TEL 029-853-5633
Email er-icu@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yujiro Matsuishi
Organization University of Tsukuba
Division name Department of Emergency and Critical Care Medicine, Faculty of Medicine
Zip code
Address 1-1-1 Tennoudai, Tsukuba-shi, Ibaraki, Japan
TEL 029-853-5633
Homepage URL
Email matsuishi.yujiro.xa@alumni.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
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 筑波大学附属病院 (茨城県)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 23 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
2015 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2016 Year 08 Month 31 Day
Date of closure to data entry
2016 Year 09 Month 30 Day
Date trial data considered complete
2016 Year 10 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information A total of 142 patients were enrolled in the present study and the total prevalence of delirium was found to be 33%, of which 26% of the patients were Type D personality.The average DCFDs was found to be 5.4 days during the week after surgery.and statistically significant association was observed between Type D personality and DCFDs based on multivariate analysis.

Management information
Registered date
2017 Year 11 Month 23 Day
Last modified on
2017 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034358

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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