UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000012563
Receipt No. R000014696
Scientific Title Investigation about the arterial pressure cardiac output measured at the time of vasoconstrictor drug medication (phenylephrine, ephedrin, etc.)
Date of disclosure of the study information 2013/12/12
Last modified on 2020/06/24 (Ver. 4)

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Basic information
Public title Investigation about the arterial pressure cardiac output measured at the time of vasoconstrictor drug medication (phenylephrine, ephedrin, etc.)
Acronym Investigation about the arterial pressure cardiac output measured at the time of vasoconstrictor drug medication
Scientific Title Investigation about the arterial pressure cardiac output measured at the time of vasoconstrictor drug medication (phenylephrine, ephedrin, etc.)
Scientific Title:Acronym Investigation about the arterial pressure cardiac output measured at the time of vasoconstrictor drug medication
Region
Japan

Condition
Condition general anesthesia patients
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Collection of the arterial pressure cardiac output measured value at the time of vasoconstrictor drug medication
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cardiac output, peripheral-vascular-resistance value
Key secondary outcomes

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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria general anesthesia patients
Key exclusion criteria patients with contineous vasoconstrictor drugs
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name takashi ichino
Organization Shinshu university school of medicine
Division name The department of anesthesiology and resusitology
Zip code
Address Asahi 3-1-1, matsumoto nagano japan
TEL 0263-37-2670
Email t_ichino@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name takashi ichino
Organization Shinshu university school of medicine
Division name The department of anesthesiology and resusitology
Zip code
Address Asahi 3-1-1, matsumoto nagano japan
TEL 0263-37-2670
Homepage URL
Email t_ichino@shinshu-u.ac.jp

Sponsor
Institute The department of anesthesiology and resusitology, Shinshu university school of medicine
Institute
Department

Funding Source
Organization Shinshu University hospital
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
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
2013 Year 12 Month 12 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
2013 Year 12 Month 01 Day
Date of IRB
2013 Year 12 Month 01 Day
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
2018 Year 12 Month 17 Day
Date of closure to data entry
2018 Year 12 Month 17 Day
Date trial data considered complete
2018 Year 12 Month 17 Day
Date analysis concluded
2018 Year 12 Month 17 Day

Other
Other related information By vasoconstrictor drug medication at the time of the blood pressure fell under anesthesia, change of a cardiac output and peripheral vascular resistance is observed in arterial pressure cardiac output measurement.

Management information
Registered date
2013 Year 12 Month 12 Day
Last modified on
2020 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014696