UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061672 |
|---|---|
| Receipt number | R000070568 |
| Scientific Title | Validation of Innovative Transcutaneous Assessment of fLuid status Using Intravenous fluid loading in healthy adults |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/05/24 11:29:43 |
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Basic information
Public title
Validation of Innovative Transcutaneous Assessment of fLuid status Using Intravenous fluid loading in healthy adults
Acronym
VITAL-FLUID Study
Scientific Title
Validation of Innovative Transcutaneous Assessment of fLuid status Using Intravenous fluid loading in healthy adults
Scientific Title:Acronym
VITAL-FLUID Study
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the validity of a newly developed transcutaneous body fluid measurement method in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Temporal changes in the body fluid index
Key secondary outcomes
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A 1-L intravenous fluid loading test using normal saline and 5% glucose solution will be performed.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Adults aged 18 years or older
2.Individuals with no history of being diagnosed with arrhythmia during health checkups or medical examinations
3.Individuals who are able to participate in the study conducted over two separate sessions
4.Individuals who have provided written informed consent for participation in the study
Key exclusion criteria
1.History of cardiovascular disease
2.Presence of any disease that may affect the cardiovascular system
3.Current use of medications that may affect the cardiovascular system
4.History of vasovagal reactions during blood sampling
5.Inability to maintain a resting position during the study procedures
6.Individuals deemed unsuitable for participation in this study by the investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Konosuke |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of cardiovascular surgery and development of oncology nursing
Zip code
9808575
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7928
konosuke.sasaki.b6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Konosuke |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of cardiovascular surgery and development of oncology nursing
Zip code
981
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7928
Homepage URL
konosuke.sasaki.b6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Hospital
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
| 2026 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 05 | Month | 24 | Day |
Last modified on
| 2026 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070568
