UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041753 |
|---|---|
| Receipt number | 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 00:08:42 |
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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
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
khatsutorit-tky@umin.org
Sponsor or person
Institute
National Center of Global Health and Medicine Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047658
| Research Plan | |
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| Registered date | File name |
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