UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between Type D personality and delirium after cardiac surgery
Title of the study (Brief title)	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	Yoshiaki inoue
Organization	University of Tsukuba
Division name	Department of Emergency and Critical Care Medicine, Faculty of Medicine
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	Yujiro Matsuishi
Organization	University of Tsukuba
Division name	Department of Emergency and Critical Care Medicine, Faculty of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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