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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030428
Receipt No. R000034743
Scientific Title The evaluations of the incident rate of and risk factors for development of cognitive dysfunction in each surgical types of cardiovascular surgery
Date of disclosure of the study information 2017/12/16
Last modified on 2019/06/16

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Basic information
Public title The evaluations of the incident rate of and risk factors for development of cognitive dysfunction in each surgical types of cardiovascular surgery
Acronym The development of and risk factor for postoperative cognitive dysfunction in cardiovascular surgery
Scientific Title The evaluations of the incident rate of and risk factors for development of cognitive dysfunction in each surgical types of cardiovascular surgery
Scientific Title:Acronym The development of and risk factor for postoperative cognitive dysfunction in cardiovascular surgery
Region
Japan

Condition
Condition Patients for cardiovascular surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study is to evaluate the incident rate and risk factors for development of postoperative cognitive dysfunction(POCD) in each type of cardiovascular surgery.
Basic objectives2 Others
Basic objectives -Others This is the observational study for development of postoperative cognitive dysfunction in cardiovascular surgeries.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes POCD was defined as a 20% score or more reduction in at least two of the neuropsychological test. The evaluation of incident rate of POCD will performed in each different types of cardiovascular surgery
Key secondary outcomes The association between the development of POCD and patients' background, humoral factors(blood concentration of symmetric dimethylarginine arginine,arginine,eicosapentaenoic acid,docosahexaenoic acid and arachidonic acid),intraoperative monitoring and factors, and postoperative factors will be evaluated.The daily life activity in 1 and 3 month postoperatively will be evaluated by questionnaire.

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 Cases of aortic valve replacement, transcatheter aortic valve implantation, mitral valve replacement or plasty, surgery for major aorta (open surgery, stent graft implantation) and off -pump CABG.
Key exclusion criteria Cases with neurological disease, symptomatic cerebral infarction,impossible for performing neuropsychological test, acute phase of infective endocarditis, emergency case and without the evaluation of chest CT and brain MRI.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyoshi Ishida
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2291
Email ishid002@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyoshi Ishida
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL 0836-22-2291
Homepage URL
Email ishid002@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

Funding Source
Organization Ministry of Education
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2017 Year 12 Month 16 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 132
Results
In 103 patients with aortic valve replacement and 29 cases with aortic aneurysm surgery under selective cerebral perfusion,arteriosclerotic changes of ascending and descending aorta and carotid were the risk factors for postoperative cognitive dysfunction. However,in these aortic surgery cases,no association of blood concentration of symmetric dimethylarginine arginine,arginine,eicosapentaenoic acid,docosahexaenoic acid and arachidonic acid with the postoperative cognitive dysfunction was observed.
Results date posted
2019 Year 06 Month 16 Day
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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective observational study for evaluating the development of postoperative cognitive dysfunction (POCD) in cardiovascular surgery cases who admit to the Yamaguchi university hospital. POCD is evaluated 7-12 postoperatively and the associating factors of it including patients background, humoral factors, intraoperative factors, intraoperative monitoring values and postoperative factors will also be evaluated in each surgery. Daily life activity will also be evaluate 1 and 3month postoperatively by questionnaire.

Management information
Registered date
2017 Year 12 Month 16 Day
Last modified on
2019 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034743

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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