UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049595 |
|---|---|
| Receipt number | R000056482 |
| Scientific Title | Assessment of the utility of esSVV and esSVI for predicting fluid responsiveness. |
| Date of disclosure of the study information | 2022/11/24 |
| Last modified on | 2023/06/18 21:12:26 |
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Basic information
Public title
Assessment of the utility of esSVV and esSVI for predicting fluid responsiveness.
Acronym
Assessment of the utility of esSVV and esSVI for predicting fluid responsiveness.
Scientific Title
Assessment of the utility of esSVV and esSVI for predicting fluid responsiveness.
Scientific Title:Acronym
Assessment of the utility of esSVV and esSVI for predicting fluid responsiveness.
Region
| Japan |
Condition
Condition
patients undergoing general anesthesia
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of the utility of esSVV and esSVI for predicting fluid responsiveness.Find the cut off value of esSVV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The value of esSVV before and after fluid loading.
Key secondary outcomes
blood pressure,heart rate,esSV,Ees/Ea
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Injection of 300ml colloids over 15 minutes during generalanesthesia.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients over the age of 20 undergoing genaral anesthesia
Key exclusion criteria
arrhythmia,pace maker,heart failure,obesity
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Matsuki |
Organization
University of Fukui Hospital
Division name
Anesthesiology
Zip code
9101103
Address
23-3,Shimoaiduki,Matsuoka,Eiheiji-cho,Yoshida-gun,Fukui,Japan
TEL
0776618391
ymatsuki@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Matsuki |
Organization
University of Fukui Hospital
Division name
Anesthesiology
Zip code
9101103
Address
23-3,Shimoaiduki,Matsuoka,Eiheiji-cho,Yoshida-gun,Fukui,Japan
TEL
0776618391
Homepage URL
ymatsuki@u-fukui.ac.jp
Sponsor or person
Institute
Aesthesiology of University of Fukui Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
NIHON KOHDEN CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of University of Fukui
Address
23-3,Shimoaiduki,Matsuoka,Eiheiji-cho,Yoshida-gun,Fukui,Japan
Tel
0776-61-8529
chiken@ml.u-fukui.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 24 | 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
| 2022 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056482
