UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036535 |
|---|---|
| Receipt number | R000041621 |
| Scientific Title | Assessment of changes in cardiac output after administration of phenylephrine: a comparison of ''Clearsight systemTM'' and transpulmonary thermodilution technique |
| Date of disclosure of the study information | 2019/04/17 |
| Last modified on | 2021/04/19 06:15:31 |
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Basic information
Public title
Assessment of changes in cardiac output after administration of phenylephrine: a comparison of ''Clearsight systemTM'' and transpulmonary thermodilution technique
Acronym
Assessment of changes in cardiac output after administration of phenylephrine: a comparison of ''Clearsight systemTM'' and transpulmonary thermodilution technique
Scientific Title
Assessment of changes in cardiac output after administration of phenylephrine: a comparison of ''Clearsight systemTM'' and transpulmonary thermodilution technique
Scientific Title:Acronym
Assessment of changes in cardiac output after administration of phenylephrine: a comparison of ''Clearsight systemTM'' and transpulmonary thermodilution technique
Region
| Japan |
Condition
Condition
Cardiovascular surgery with cardiopulmonary bypass
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare ''Clearsight systemTM'' to intermittent thermodilution technique regarding cardiac output change after phenylephrine administration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bland-Altman analysis for cardiac output after phenylephrine administration measured by ''Clearsight systemTM'' and thermodilution technique.
Key secondary outcomes
The correlation coefficient for cardiac output change after phenylephrine administration measured by ''Clearsight systemTM'' and thermodilution technique.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients scheduled for elective cardiovascular surgery under cardiopulmonary bypass
Key exclusion criteria
1) emergency surgery
2) Patients who have upper extremity arteriovenous fistula
3) Patients with cardiac arrhythmia
4) Patients with moderate or severe aortic regurgitation
5) Patients treated with intra-aortic balloon pumping
Target sample size
173
Research contact person
Name of lead principal investigator
| 1st name | Akari |
| Middle name | |
| Last name | Yoshida |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan
TEL
073-441-0611
akari@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Akari |
| Middle name | |
| Last name | Yoshida |
Organization
Wakayama Medical University
Division name
Department of Anesthesiology
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan
TEL
073-441-0611
Homepage URL
akari@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.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
| 2019 | Year | 04 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cardiac output is measured before and after phenylephrine administration by using ''Clearsight systemTM'' and a pulmonary artery catheter.
Management information
Registered date
| 2019 | Year | 04 | Month | 17 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041621
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
