UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034414 |
|---|---|
| Receipt number | R000039246 |
| Scientific Title | The effect of phenylephrine on hemodynamic parameters and cardiac performance in patients with heart diseases |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2025/07/25 15:40:02 |
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Basic information
Public title
The effect of phenylephrine on hemodynamic parameters and cardiac performance in patients with heart diseases
Acronym
The effect of phenylephrine on hemodynamics
Scientific Title
The effect of phenylephrine on hemodynamic parameters and cardiac performance in patients with heart diseases
Scientific Title:Acronym
The effect of phenylephrine on hemodynamics
Region
| Japan |
Condition
Condition
coronary heart diseases
aortic stenosis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of phenylephrine on cardiovascular parameters and cardiac performance,
when the patient's blood pressure decreases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ejection fraction, E/e'
Key secondary outcomes
systemic and pulmonary arterial pressure
heart rate, central venous pressure
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with coronary heart disease or aortic stnosis.
2.Patients whoes systolic blood pressure was decreases to 90 or less than 90 mmHg after induction anesthesia and before start of the operation.
Key exclusion criteria
Mirtal regurgitatio II or more
Aortic regurgitation II or more
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Hayashi |
Organization
Sakurabashi-Watanabe Hospital
Division name
Anesthesiology
Zip code
Address
2-4-32, Umeda, Kita-ku, Osaka, JAPAN
TEL
06-6341-8651
yhayashi@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Hayashi |
Organization
Sakurabashi- Watanabe Hospital
Division name
Anesthesiology
Zip code
Address
2-4-32, Umeda, Kita-ku, Osaka, JAPAN
TEL
06-6341-8651
Homepage URL
yhayashi@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Anesthesiology, Sakurabashi-Watanabe Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 10 | Month | 15 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
Nine
Number of participants that the trial has enrolled
12
Results
The study is over. We cannot obtain useful results.
Results date posted
| 2025 | Year | 05 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with coronary artery disease
Participant flow
No follow
Adverse events
None
Outcome measures
Change of cardiac function after phenylephrine adimistration.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 08 | Month | 15 | Day |
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039246
