UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034414
Receipt No. 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 2019/10/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yhayashi@anes.med.osaka-u.ac.jp

Sponsor
Institute Anesthesiology, Sakurabashi-Watanabe Hospital
Institute
Department

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
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 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

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 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
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 10 Month 09 Day
Last modified on
2019 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039246

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.