UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009560
Receipt number R000011216
Scientific Title Investigation for risk factors which may affect left ventricular failure after mitral regurgitation surgery
Date of disclosure of the study information 2012/12/16
Last modified on 2013/12/15 17:03:51

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Basic information

Public title

Investigation for risk factors which may affect left ventricular failure after mitral regurgitation surgery

Acronym

Investigation for risk factors which may affect left ventricular failure after mitral regurgitation surgery

Scientific Title

Investigation for risk factors which may affect left ventricular failure after mitral regurgitation surgery

Scientific Title:Acronym

Investigation for risk factors which may affect left ventricular failure after mitral regurgitation surgery

Region

Japan


Condition

Condition

Mitral regurgitation

Classification by specialty

Anesthesiology Cardiovascular surgery Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the present study is investigation of the relationship between left ventricular failure after mitral regurgitation surgery and following factors; intraoperative cerebral tissue oxygen saturation, intraoperative plasma reactive oxygen species levels, central venous oxygen saturation, and mixed venous oxygen saturation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome is postoperative left ventricular failure. It is defined that left ventricular ejection fraction is less than 50 %, which measurement is performed in transthoracic echocardiography during postoperative 5 - 21 days.

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 mitral valve plasty or mitral valve replacement for severe mitral valve regurgitation

Key exclusion criteria

Patients who don't agree to participate in this study
Patients whose preoperative ejection fractions are less than 50 percent

Target sample size

51


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuaki Tanaka

Organization

Osaka City University Graduate School of Medicine

Division name

Anesthesiology

Zip code


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
Middle name
Last name Katsuaki Tanaka

Organization

Osaka City University Graduate School of Medicine

Division name

Anesthesiology

Zip code


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


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

2012 Year 12 Month 16 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2012 Year 09 Month 28 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 17 Day

Last follow-up date


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
serum active oxygen species level


Management information

Registered date

2012 Year 12 Month 15 Day

Last modified on

2013 Year 12 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011216


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name