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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010195
Receipt No. R000011942
Scientific Title Validation of tissue doppler imaging as prognostic factor in patients who had undergone cardiovascular surgeries
Date of disclosure of the study information 2013/03/10
Last modified on 2020/03/20

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Basic information
Public title Validation of tissue doppler imaging as prognostic factor in patients who had undergone cardiovascular surgeries
Acronym Validation of tissue doppler imaging as prognostic factor in patients who had undergone cardiovascular surgeries
Scientific Title Validation of tissue doppler imaging as prognostic factor in patients who had undergone cardiovascular surgeries
Scientific Title:Acronym Validation of tissue doppler imaging as prognostic factor in patients who had undergone cardiovascular surgeries
Region
Japan

Condition
Condition Cardiac Disease
Greater Vessel Disease
Classification by specialty
Anesthesiology Cardiovascular surgery Intensive care medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the significance of tricuspid annular velocity or of left atrial wall velocity for the prediction of postoperative complications after cardiovascular surgeries
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postoperative mortality
postoperative morbidity
prolonged ICU stay
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who undergo cardiovascular surgery under general anesthesia
Key exclusion criteria Patients who don't agree to participate in this study
Patients who don't undergo transesophageal echocardiography
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Katsuaki
Middle name
Last name Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Anesthesiology
Zip code 545-8586
Address 1-5-7, Asahimachi, Abeno-ku, Osaka 545-8585 Japan
TEL 06-6645-2186
Email anesth@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Katsuaki
Middle name
Last name Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Anesthesiology
Zip code 545-8586
Address 1-5-7, Asahimachi, Abeno-ku, Osaka 545-8585 Japan
TEL 06-6645-2186
Homepage URL
Email anesth@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine
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 Ethics Committee of Osaka City University Graduate School of Medicine
Address 1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan
Tel 81-6-6646-6125
Email ethics@med.osaka-cu.ac.jp

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
2013 Year 03 Month 10 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 100
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 Completed
Date of protocol fixation
2012 Year 12 Month 28 Day
Date of IRB
2013 Year 02 Month 01 Day
Anticipated trial start date
2013 Year 03 Month 11 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Perioperative monitoring of the following is considered:
electrocardiogram
non invasive blood pressure
invasive blood pressure
pulse rate
pulseoximetry
capnometry
bispectral index score
transesophageal echocardiography
central venous pressure
pulmonary arterial pressure
cerebral tissue oxygen saturation
arterial blood gas assay

Management information
Registered date
2013 Year 03 Month 09 Day
Last modified on
2020 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011942

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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