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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019883
Receipt No. R000022969
Scientific Title Association between regional cerebral oxygen desaturation during cardiac surgery and postoperative cognitive dysfunction, and adverse events
Date of disclosure of the study information 2015/11/24
Last modified on 2018/06/18

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Basic information
Public title Association between regional cerebral oxygen desaturation during cardiac surgery and postoperative cognitive dysfunction, and adverse events
Acronym Association between regional cerebral oxygen saturation and postoperative cognitive dysfunction
Scientific Title Association between regional cerebral oxygen desaturation during cardiac surgery and postoperative cognitive dysfunction, and adverse events
Scientific Title:Acronym 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
1st name
Middle name
Last name Ken Yamaura
Organization Fukuoka University Faculty of Medicine
Division name Anesthesiology
Zip code
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
1st name
Middle name
Last name Kouhei Iwashita
Organization Fukuoka University Faculty of Medicine
Division name Anesthesiology
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 24 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 Enrolling by invitation
Date of protocol fixation
2015 Year 09 Month 29 Day
Date of IRB
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

Other
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

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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