UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026729 |
|---|---|
| Receipt number | 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 09:27:03 |
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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
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
sohtamikaze@gmail.com
Sponsor or person
Institute
National Cerebral and CardioVascular Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
