UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000011942