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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031887
Receipt No. R000036405
Scientific Title Assessment of changes in cardiac output after administration of phenylephrine: a comparison of ''Clearsight system TM'' and transpulmonary thermodilution technique: a pilot study
Date of disclosure of the study information 2018/03/25
Last modified on 2018/12/27

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Basic information
Public title Assessment of changes in cardiac output after administration of phenylephrine: a comparison of ''Clearsight system TM'' and transpulmonary thermodilution technique: a pilot study
Acronym Assessment of changes in cardiac output after administration of phenylephrine: a comparison of ''Clearsight system TM'' and transpulmonary thermodilution technique: a pilot study
Scientific Title Assessment of changes in cardiac output after administration of phenylephrine: a comparison of ''Clearsight system TM'' and transpulmonary thermodilution technique: a pilot study
Scientific Title:Acronym Assessment of changes in cardiac output after administration of phenylephrine: a comparison of ''Clearsight system TM'' and transpulmonary thermodilution technique: a pilot study
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 system TM'' 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 The correlation coefficient for cardiac output change after phenylephrine administration measured by ''Clearsight system TM'' and thermodilution technique.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Cardiac output is measured before and after phenylephrine administration by using ''Clearsight system TM'' and a pulmonary artery catheter.
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 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akari Yoshida
Organization Wakayama Medical University
Division name Department of Anesthesiology
Zip code
Address 811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan
TEL 073-441-0611
Email akari@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akari Yoshida
Organization Wakayama Medical University
Division name Department of Anesthesiology
Zip code
Address 811-1 Kimiidera, Wakayama city, Wakayama 641-0012, Japan
TEL 073-441-0611
Homepage URL
Email akari@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Department of Anesthesiology
Institute
Department

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
Address
Tel
Email

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
2018 Year 03 Month 25 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 Completed
Date of protocol fixation
2017 Year 11 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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
2018 Year 03 Month 25 Day
Last modified on
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036405

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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