UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013547 |
|---|---|
| Receipt number | R000015816 |
| Scientific Title | A comparison of the fourth-generation FloTrac-Vigileo system with thermodilution in the patients undergoing cardiac surgery. |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/02/12 21:02:39 |
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Basic information
Public title
A comparison of the fourth-generation FloTrac-Vigileo system with thermodilution in the patients undergoing cardiac surgery.
Acronym
A comparison of the FloTrac-Vigileo system with thermodilution in cardiac surgery patients.
Scientific Title
A comparison of the fourth-generation FloTrac-Vigileo system with thermodilution in the patients undergoing cardiac surgery.
Scientific Title:Acronym
A comparison of the FloTrac-Vigileo system with thermodilution in cardiac surgery patients.
Region
| Japan |
Condition
Condition
Patients undergoing cardiovascular surgery with cardiopulmonary bypass.
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate validity of cardiac output derived from the fourth-generation Flotrac-Vigileo system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac output
Key secondary outcomes
Heart rate, femoral arterial pressure, radial arterial pressure, pulmonary arterial pressure, central venous pressure, mixed venous oxygen saturation, body temperature.
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Perioperative simultaneous measurement of cardiac output by the Flotrac-Vigileo system and bolus thermodilution using a pulmonary artery catheter.
Interventions/Control_2
Cardiac output is measured at eleven time points: after induction of general anesthesia, at the start of surgery, after sternotomy, before and after administration of heparine, before and after administration of protamine, at the start of sternal closure, at the end of surgery, on arrival to intensive care unit.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cardiovascular surgery with cardiopulmonary bypass.
Key exclusion criteria
Severe aortic regurgitation
Cardiac arrhythmia
Use of IABP
Left ventricular ejection fraction under 40%
Intra cardiac shunt
Aortic dissection
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigakumachi, Takatsuki, Osaka, 569-8686, Japan
TEL
072-683-1221
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Kusaka |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigakumachi, Takatsuki, Osaka, 569-8686, Japan
TEL
072-683-1221
Homepage URL
Y.kusaka1978@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Osaka Medical College
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
| 2014 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
Management information
Registered date
| 2014 | Year | 03 | Month | 28 | Day |
Last modified on
| 2015 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015816
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