UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000022630
Receipt No. 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 (Ver. 6)

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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
Institute Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026083