UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044828 |
|---|---|
| Receipt number | R000051030 |
| Scientific Title | Standardization of Body fluid evaluation in Specified Medical Acts using body composition analyzer and its application for the training of nurses completing the educational program. |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/07/12 12:14:58 |
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Basic information
Public title
Standardization of Body fluid evaluation in Specified Medical Acts using body composition analyzer and its application for the training of nurses completing the educational program.
Acronym
Standardization of Body fluid evaluation in Specified Medical Acts using body composition analyzer and its application for the training of nurses completing the educational program.
Scientific Title
Standardization of Body fluid evaluation in Specified Medical Acts using body composition analyzer and its application for the training of nurses completing the educational program.
Scientific Title:Acronym
Standardization of Body fluid evaluation in Specified Medical Acts using body composition analyzer and its application for the training of nurses completing the educational program.
Region
| Japan |
Condition
Condition
dehydration
Classification by specialty
| Nephrology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. In implementing the specific action category "drug administration related to nutrition and water management", we will use the bioimpedance method to incorporate objective indicators into body fluid volume evaluation and establish a universal evaluation method.
2. The results of body fluid volume evaluation by the bioimpedance method will be fed back to the assessment of the specific action performer, which will lead to the improvement of the practical ability of those who have completed the specific action training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To establish the objective index by using a body composition analyzer to the evaluation of body fluid volume by comparing it with the evaluation by physical findings and conventional laboratory findings.
Key secondary outcomes
To improve the accuracy of fluid volume evaluation in specific actions of nurses by utilizing the objective index of the body composition analyzer.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Evaluate body fluid volume using bioimpedance method.
This step will be applied only one time for each evaluation when planning an infusion plan.
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria.
1) Disease name and diagnostic method: Patients with suspected or potentially dehydrated dehydration
2) Provisions for stage, type, and pathology: Evaluate the patient's condition according to the procedure manual for specific actions specified separately, confirm that the patient condition is within the scope of the procedure manual, and include it in the target.
3) Age: Patients aged 20 years or older at the time of consent acquisition
4) Gender: Gender does not matter
5) Indicators of general condition: vital signs, stable respiratory and circulatory dynamics
6) Related major organ functions: Heart function and renal function are maintained
7) Written consent of the research subject or surrogate: Patients who have voluntarily consented to the document
Key exclusion criteria
Patients who fall under any of the following will not be included in this study.
1) Conditions related to heart disease: Concomitant with unstable angina or a history of myocardial infarction within 6 months. Patients with heart failure symptoms
2) Women who are pregnant or may become pregnant
3) Implants with conductive implants such as pacemakers
4) When the principal investigator and the research coordinator judge that participation in this research is not appropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takamoto |
| Middle name | |
| Last name | Ohse |
Organization
JCHO Tokyo Shinjuku Medical Center
Division name
Division of Nephrology
Zip code
162-8543
Address
5-1 Tsukudo-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3269-8111
toose-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takamoto |
| Middle name | |
| Last name | Ohse |
Organization
JCHO Tokyo Shinjuku Medical Center
Division name
Division of Nephrology
Zip code
162-8543
Address
5-1 Tsukudo-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3269-8111
Homepage URL
toose-tky@umin.ac.jp
Sponsor or person
Institute
JAPAN COMMUNITY HEALTH CARE ORGANIZATION
Institute
Department
Personal name
Funding Source
Organization
JAPAN COMMUNITY HEALTH CARE ORGANIZATION
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
JCHO Tokyo Shinjuku Medical Center
Address
5-1 Tsukudo-cho, Shinjuku-ku, Tokyo, Japan
Tel
03-3269-8111
toose-tky@umin.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
| 2021 | Year | 10 | 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
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2021 | Year | 07 | Month | 12 | Day |
Last modified on
| 2021 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051030
