UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008307
Receipt number R000009783
Scientific Title Significance of the difference between ScvO2 and Svo2 for the prediction of prognosis after cardiac surgery
Date of disclosure of the study information 2012/06/30
Last modified on 2013/12/30 12:42:35

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Basic information

Public title

Significance of the difference between ScvO2 and Svo2 for the prediction of prognosis after cardiac surgery

Acronym

Significance of the difference between ScvO2 and Svo2 for the prediction of prognosis after cardiac surgery

Scientific Title

Significance of the difference between ScvO2 and Svo2 for the prediction of prognosis after cardiac surgery

Scientific Title:Acronym

Significance of the difference between ScvO2 and Svo2 for the prediction of prognosis after cardiac surgery

Region

Japan


Condition

Condition

Cardiac Disease
Greater Vessel Disease

Classification by specialty

Cardiology Vascular surgery Anesthesiology
Cardiovascular surgery Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the significance of differences between ScvO2 and SvO2 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

ICU duration
Ventilation time
Death
Major organ morbidity and mortality

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 underwent cardiovascular surgery under general anesthesia

Key exclusion criteria

Patients who were failed to be placed central venous catheters or pulmonary arterial catheters

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoharu Funao

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 06 Month 30 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/23972741

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

2011 Year 06 Month 29 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

logistic regression analysis


Management information

Registered date

2012 Year 06 Month 30 Day

Last modified on

2013 Year 12 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009783


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name