UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010195
Receipt number 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 12:29:23

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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 or person

Institute

Osaka City University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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