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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031336
Receipt No. R000035776
Scientific Title Preoperative volume and hemodynamic assessment with echocardiography in patients with hypovolemia or cardiac dysfunction
Date of disclosure of the study information 2018/02/19
Last modified on 2019/08/20

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Basic information
Public title Preoperative volume and hemodynamic assessment with echocardiography in patients with hypovolemia or cardiac dysfunction
Acronym Preoperative volume assessment with echocardiography.
Scientific Title Preoperative volume and hemodynamic assessment with echocardiography in patients with hypovolemia or cardiac dysfunction
Scientific Title:Acronym Preoperative volume assessment with echocardiography.
Region
Japan

Condition
Condition patients unable to take preoperative oral fluid
Classification by specialty
Hepato-biliary-pancreatic surgery Obsterics and gynecology Orthopedics
Urology Anesthesiology Neurosurgery
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The relationship between preoperative volume status, cardiac function and post-induction hemodynamics.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between pre-induction caliber, respiratory variation and flow of SVC or IVC and post-induction blood pressure.
Key secondary outcomes Effects of pre-induction caliber, respiratory variation and flow of SVC or IVC on post-induction respiratory variation of pulse 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

Not applicable
Gender Male and Female
Key inclusion criteria patients undergoing general anesthesia and being unable to take preoperative oral fluid
Key exclusion criteria Unable to reliably assess caliber, respiratory variation and flow of either IVC or SVC with echocardiography
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoshifumi
Middle name
Last name Kotake
Organization Toho University Ohashi Medical Center
Division name Department of Anesthesiology
Zip code 153-8515
Address 2-17-6 Ohashi, Meguro, Tokyo, Japan
TEL 03-3468-1251
Email ykotake@med.toho-u.ac.jp

Public contact
Name of contact person
1st name yoshifumi
Middle name
Last name Kotake
Organization Toho University Ohashi Medical Center
Division name Department of Anesthesiology
Zip code 153-8515
Address 2-17-6 Ohashi, Meguro, Tokyo, Japan
TEL 03-3468-1251
Homepage URL http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
Email ykotake@med.toho-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department

Funding Source
Organization Japan Society for the promotion of science
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics commitee, Toho university ohashi medical center
Address 2-17-6, Ohashi Meguro Tokyo
Tel 03-3468-1251
Email secretary@oha.toho-u.ac.jp

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 東邦大学医療センター大橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 19 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 Enrolling by invitation
Date of protocol fixation
2018 Year 01 Month 31 Day
Date of IRB
2017 Year 12 Month 25 Day
Anticipated trial start date
2018 Year 02 Month 26 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 04 Month 30 Day
Date trial data considered complete
2020 Year 04 Month 30 Day
Date analysis concluded
2020 Year 07 Month 31 Day

Other
Other related information This observational study aims to evaluate the relationship between pre-induction volume status assessed by echocardiography and post-induction blood pressure.

Management information
Registered date
2018 Year 02 Month 16 Day
Last modified on
2019 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035776

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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