UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008882 |
|---|---|
| Receipt number | R000010423 |
| Scientific Title | Relationship between ScvO2-SvO2 difference, cerebral tissue oxygen saturation and plasma reactive oxygen species level in cardiovascular surgery patients |
| Date of disclosure of the study information | 2012/09/10 |
| Last modified on | 2014/09/16 22:21:59 |
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Basic information
Public title
Relationship between ScvO2-SvO2 difference, cerebral tissue oxygen saturation and plasma reactive oxygen species level in cardiovascular surgery patients
Acronym
Relationship between ScvO2-SvO2 difference, cerebral tissue oxygen saturation and plasma reactive oxygen species level in cardiovascular surgery patients
Scientific Title
Relationship between ScvO2-SvO2 difference, cerebral tissue oxygen saturation and plasma reactive oxygen species level in cardiovascular surgery patients
Scientific Title:Acronym
Relationship between ScvO2-SvO2 difference, cerebral tissue oxygen saturation and plasma reactive oxygen species level in cardiovascular surgery patients
Region
| Japan |
Condition
Condition
Cardiac Disease
Greater Vessel Disease
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 the investigation of the relationship among ScvO2-Svo2 difference, brain tissue oxygen saturation and plasma reactive oxygen species level in cardiovascular surgery patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the validation of relationship among ScvO2-Svo2 difference, brain tissue oxygen saturation and plasma reactive oxygen species level.
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 with cardiopulmonary bypass under general anesthesia
Key exclusion criteria
Patients whose greater veins are not cannulated with 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
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
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
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 | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/24967764
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 | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
electrocardiogram, non invasive blood pressure, invasive blood pressure, pulse rate, pulse oximetry, end-tidal carbon dioxide, Bispectral index, transesophageal echocardiography, central venous pressure, pulmonary arterial pressure, near infrared spectrometry, arterial blood gas assay, plasma reactive oxygen species assay
Management information
Registered date
| 2012 | Year | 09 | Month | 09 | Day |
Last modified on
| 2014 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010423
