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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041753
Receipt No. R000047658
Scientific Title The explaratory research for diagnostic biomarker of postoperative delirium and cognitive dysfunction in the patients with cardiovascular diseases
Date of disclosure of the study information 2020/10/01
Last modified on 2020/09/11

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Basic information
Public title The explaratory research for diagnostic biomarker of postoperative delirium and cognitive dysfunction in the patients with cardiovascular diseases
Acronym The explaratory research for diagnostic biomarker of postoperative delirium and cognitive dysfunction
Scientific Title The explaratory research for diagnostic biomarker of postoperative delirium and cognitive dysfunction in the patients with cardiovascular diseases
Scientific Title:Acronym The explaratory research for diagnostic biomarker of postoperative delirium and cognitive dysfunction in the patients with cardiovascular diseases
Region
Japan

Condition
Condition postoperative delirium and cognitive dysfunction
Classification by specialty
Anesthesiology Operative medicine Intensive care medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We verify that the potential biomarkers, which can be activated by neuroinflammtion and CNS damage, are correlated with postoperative delirium diagnosed by a CAM-ICU procedure.
Further, we also quantitatively evaluate that these agents can affect postoperative cognitive dysfunction.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) positive ratio of postoperative delirium diagnosed by using CAM-ICU
2) activity of P2Y12 receptor
3) serum concentration of neuron specific enolase
4) serum concentration of phosphorylated neurofilament heavy subunit
5) quantitative cognitive function by using NIH toolbox and its variability in perioperative period
Key secondary outcomes

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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1) those who consented the participation to the study in a written form
2) those who are 20 to 100 years old, male and female
3) those who undergo a cardiovascular operation or a non-cardiovascular operation with cardiovascular disease under general anesthesia performed by an anesthesiologist
4) those who have their blood pressure measured by direct arterial sphygmomanometry
5) those who undergo postoperative care at ICU or HCU
Key exclusion criteria 1) the patients with a tumor in brain or spinal cord
2) the patients who regularly use minor tranquilizer before surgery
3) the patients already sedated before surgery
4) the patients who are unable to make themselves understood in neither Japanese nor English
5) the patients with severe impairment with visual or hearing
6) the participants who suspended cognitive function test over the predetermined time
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kohshi
Middle name
Last name Hattori
Organization National Center of Global Health and Medicine Hospital
Division name Department of Anesthesiology
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL 03-3202-7181
Email khatsutori-tky@umin.org

Public contact
Name of contact person
1st name Kohshi
Middle name
Last name Hattori
Organization National Center of Global Health and Medicine Hospital
Division name Department of Anesthesiology
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL 03-3202-7181
Homepage URL
Email khatsutorit-tky@umin.org

Sponsor
Institute National Center of Global Health and Medicine Hospital
Institute
Department

Funding Source
Organization Japan Society of the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center of Global Health and Medicine Hospital
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
Tel 03-3202-7181
Email khatsutori-tky@umin.org

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
2020 Year 10 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2022 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We collect a blood sample intraoperatively and postoperatively (POD 3), and measure the serum level of potential biomarkers.
We screen postoperative delirium by using CAM-ICU just after surgery, postoperateive day 1 to 3.
We quantitatively evaluate cognitive function before surgery, after surgery in ICU, and at the first outpatient after surgery.

Management information
Registered date
2020 Year 09 Month 11 Day
Last modified on
2020 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047658

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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