UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022630
Receipt number R000026083
Scientific Title Venous arterial CO2 tension to arterial venous O2 difference ratio as a predictor of postoperative complications in cardiac surgery
Date of disclosure of the study information 2016/06/06
Last modified on 2019/12/09 11:10:49

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Basic information

Public title

Venous arterial CO2 tension to arterial venous O2 difference ratio as a predictor of postoperative complications in cardiac surgery

Acronym

Venous arterial CO2 tension to arterial venous O2 difference ratio in cardiac surgery

Scientific Title

Venous arterial CO2 tension to arterial venous O2 difference ratio as a predictor of postoperative complications in cardiac surgery

Scientific Title:Acronym

Venous arterial CO2 tension to arterial venous O2 difference ratio in cardiac surgery

Region

Japan


Condition

Condition

Patients undergoing cardiac surgery

Classification by specialty

Anesthesiology Cardiovascular surgery Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the predictive ability of venous arterial CO2 to arterial venous O2 content difference ratio for postoperative complications after cardiac surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The occurrence of severe postoperative complications

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 without pulmonary artery catheter
Patients with hemodialysis
Patients with intracardiac shunt

Target sample size

110


Research contact person

Name of lead principal investigator

1st name Koichi
Middle name
Last name Suehiro

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

545-8586

Address

1-5-7, Asahimachi, Abeno-ku, Osaka 545-8585 Japan

TEL

06-6645-2186

Email

suehirokoichi@yahoo.co.jp


Public contact

Name of contact person

1st name Koichi
Middle name
Last name Suehiro

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Anesthesiology

Zip code

545-8586

Address

1-5-7, Asahimachi, Abeno-ku, Osaka 545-8585 Japan

TEL

06-6645-2186

Homepage URL


Email

suehirokoichi@yahoo.co.jp


Sponsor or person

Institute

Department of Anesthesiology, Osaka City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Osaka City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 06 Month 06 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007%2Fs10877-019-00286-z

Number of participants that the trial has enrolled

110

Results

MOMM events occurred in 25 patients (22.7%). ROC curve analysis revealed that both postoperative Pv-aCO2/Ca-vO2 and Pcv-aCO2/Ca-cvO2 were significant predictors of MOMM. However, postoperative Pv-aCO2 was the best predictor of MOMM.Multivariate analysis revealed that postoperative Pv-aCO2 was an independent predictor of MOMM.

Results date posted

2019 Year 12 Month 09 Day

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

2016 Year 05 Month 01 Day

Date of IRB

2016 Year 06 Month 05 Day

Anticipated trial start date

2016 Year 06 Month 06 Day

Last follow-up date

2019 Year 02 Month 22 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

ROC analysis and logistic regression analysis will be conducted to investigate the predictive ability of the venous arterial CO2 to arterial venous O2 content difference ratio for severe postoperative complications.
Severe postoperative complications are defined as follows:
a) prolonged ventilation for more than 48hours
b) renal failure requiring dialysis
c) stroke
d) re-operation
e) deep sternal infection
f) death.


Management information

Registered date

2016 Year 06 Month 06 Day

Last modified on

2019 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026083


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name