UMIN-CTR Clinical Trial

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
Email	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
Email	toose-tky@umin.ac.jp

Sponsor
Institute	JAPAN COMMUNITY HEALTH CARE ORGANIZATION
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051030