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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035220
Receipt No. R000039790
Scientific Title Influence of anesthetics on cardiac dilatability of cardiovascular surgery patients
Date of disclosure of the study information 2018/12/11
Last modified on 2018/12/11

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Basic information
Public title Influence of anesthetics on cardiac dilatability of cardiovascular surgery patients
Acronym Influence of anesthetics on cardiac dilatability of cardiovascular surgery patients
Scientific Title Influence of anesthetics on cardiac dilatability of cardiovascular surgery patients
Scientific Title:Acronym Influence of anesthetics on cardiac dilatability of cardiovascular surgery patients
Region
Japan

Condition
Condition Valvular heart disease
Angina pectoris
Myocardial infarction
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the change in cardiac dilatability following introduction of anesthesia
Basic objectives2 Others
Basic objectives -Others to be clinically applicable to the existence of changes in diastolic capacity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in cardiac dilatation ability before surgery due to use of anesthetic
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 Patients undergoing cardiovascular operations
Key exclusion criteria Patients whose preoperative cardiac echography did not measure E/e'.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Hayashi
Organization Sakurabashi Watanabe Hospital
Division name Anesthesiology
Zip code
Address 2-4-32 Umeda Kita-ku, Osaka-shi, Osaka
TEL 06-6341-0785
Email yhayashi@anes.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Fujimoto
Organization Sakurabashi Watanabe Hospital
Division name Anesthesiology
Zip code
Address 2-4-32 Umeda Kita-ku, Osaka-shi, Osaka
TEL 06-6341-0785
Homepage URL
Email tomotomotomo0813@yahoo.co.jp

Sponsor
Institute Sakurabashi Watanabe Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2018 Year 12 Month 11 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
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2018 Year 12 Month 11 Day
Last modified on
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039790

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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