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Recruitment status Completed
Unique ID issued by UMIN UMIN000015047
Receipt No. R000017381
Scientific Title Investigation of hemodynamic change using Electrical Cardiometry (AESCULON) in modified electroconvulsive therapy.
Date of disclosure of the study information 2014/09/16
Last modified on 2017/05/06

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Basic information
Public title Investigation of hemodynamic change using Electrical Cardiometry (AESCULON) in modified electroconvulsive therapy.
Acronym Investigation of hemodynamic change using Electrical Cardiometry (AESCULON) in modified electroconvulsive therapy.
Scientific Title Investigation of hemodynamic change using Electrical Cardiometry (AESCULON) in modified electroconvulsive therapy.
Scientific Title:Acronym Investigation of hemodynamic change using Electrical Cardiometry (AESCULON) in modified electroconvulsive therapy.
Region
Japan

Condition
Condition Patients who are undergoing modified electroconvulsive therapy in Hamamatsu University School of Medicine
Classification by specialty
Psychiatry Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the hemodynamic change throughout the period of modified electroconvulsive therapy not only one-time but also change over the time.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes HR,BP,CO,CI,SVV,SVR,SVRI,etc.(Indices that can be obtained by AESCULON.)
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 using Electrical Cardiometry (AESCULON®)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients over 18 years old who underging modified electroconvulsive therapy
Key exclusion criteria Patients whose skin attaching electrodes has trouble
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuya Kawashima
Organization Hamamatsu University Hospital
Division name Department of Anesthesiology and Intensive Care
Zip code
Address 1-20-1, Handayama, Hamamatsu-shi, Shizuoka-ken
TEL 053-435-2111
Email yuyak@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name MORISHITA Kaho
Organization Hamamatsu University Hospital
Division name Department of Anesthesiology and Intensive Care
Zip code
Address 1-20-1, Handayama, Hamamatsu-shi, Shizuoka-ken
TEL 053-435-2111
Homepage URL
Email ryuu-ham@umin.ac.jp

Sponsor
Institute Hamamatsu University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Hamamatsu University Hospital
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 浜松医科大学附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 16 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
2014 Year 08 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 16 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 09 Month 03 Day
Last modified on
2017 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017381


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