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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026729
Receipt No. R000030685
Scientific Title Observational study on postoperative cognitive function of the patients with cardiovascular surgery and the intestinal flora
Date of disclosure of the study information 2017/10/01
Last modified on 2017/11/07

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Basic information
Public title Observational study on postoperative cognitive function of the patients with cardiovascular surgery and the intestinal flora
Acronym Observational study on postoperative cognitive function of the patients with cardiovascular surgery and the intestinal flora
Scientific Title Observational study on postoperative cognitive function of the patients with cardiovascular surgery and the intestinal flora
Scientific Title:Acronym Observational study on postoperative cognitive function of the patients with cardiovascular surgery and the intestinal flora
Region
Japan

Condition
Condition Delirium after surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to investigate the influence of heart and large vessel surgery using artificial heart - lung on the cognitive function after operation and intestinal bacteria.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between distribution change of intestinal flora and occurrence of delirium after surgery
Key secondary outcomes Correlation between intestinal bacterial flora and detection data of blood bacteria and various inspection items and intensive care unit stay time, correlation with ventilator time, correlation with renal function after surgery, correlation with postoperative cardiac function

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
85 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing cardiac / macrovascular surgery using cardiopulmonary bypass
Key exclusion criteria 1) Patients under 20 years old, over 85 years old
2)Dialysis patients
3)Patients who the research researcher or shared medical doctor deems inappropriate to participate in incidental research
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Kubota
Organization National Cerebral and CardioVascular Center
Division name Anesthesiolosy
Zip code
Address Osaka-hu fujisirodai 5-7-1
TEL 0668335012
Email carvy26@me.com

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Yoshitani
Organization National Cerebral and CardioVascular Center
Division name Surgery department
Zip code
Address Osaka-hu fujisirodai 5-7-1
TEL 0668335012
Homepage URL
Email sohtamikaze@gmail.com

Sponsor
Institute National Cerebral and CardioVascular Center
Institute
Department

Funding Source
Organization National Cerebral and CardioVascular Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Yakult Honsya Co., Ltd
Name of secondary funder(s) National Cerebral and Cardiovascular Center Research Institute

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 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
2017 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
2021 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 03 Month 28 Day
Last modified on
2017 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030685

Research Plan
Registered date File name
2017/09/28 倫理員会 研究計画書 腸内フローラー心臓手術研究 9月28日.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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