UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between regional cerebral oxygen desaturation during cardiac surgery and postoperative cognitive dysfunction, and adverse events
Title of the study (Brief title)	Association between regional cerebral oxygen saturation and postoperative cognitive dysfunction
Region	Japan

Condition
Condition	Patients scheduled for cardiac surgery
Classification by specialty	Anesthesiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Regional cerebral oxygen saturation (ScO2) is determined by near infrared spectroscopy (NIRS). Until now, NIRS has used two wavelength, but now, NIRS with five wavelength is available. We will investigate an association between decrease of ScO2 determined by NIRS with 5 wavelength during cardiac surgery and postoperative cognitive dysfunction, and adverse events.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative cognitive dysfunction
Key secondary outcomes	delirium mortality organ dysfunction length of a hospital stay

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients scheduled for cardiac surgery
Key exclusion criteria	emergency case
Target sample size	100

Research contact person
Name of lead principal investigator	Ken Yamaura
Organization	Fukuoka University Faculty of Medicine
Division name	Anesthesiology
Address	7-45-1, Nanakuma, Jonan-ku, Fukuoka, Japan
TEL	+81-92-801-1011
Email	keny@fukuoka-u.ac.jp

Public contact
Name of contact person	Kouhei Iwashita
Organization	Fukuoka University Faculty of Medicine
Division name	Anesthesiology
Address	7-45-1, Nanakuma, Jonan-ku, Fukuoka, Japan
TEL	+81-92-801-1011
Homepage URL
Email	iwashita@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Hospital
Institute
Department

Funding Source
Organization	Century Medical, Inc.
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 24 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 09 Month 29 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Enrolling by invitation

Management information
Registered date	2015 Year 11 Month 20 Day
Last modified on	2018 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022969