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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039088
Receipt No. R000044466
Scientific Title Continuous body weight measurements with contact-free unconstraint load cells under the bed in patients with acute cardiac failure
Date of disclosure of the study information 2020/01/10
Last modified on 2020/01/08

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Basic information
Public title Continuous body weight measurements with contact-free unconstraint load cells under the bed in patients with acute cardiac failure
Acronym Continuous body weight measurements in patients with acute cardiac failure
Scientific Title Continuous body weight measurements with contact-free unconstraint load cells under the bed in patients with acute cardiac failure
Scientific Title:Acronym Continuous body weight measurements in patients with acute cardiac failure
Region
Japan

Condition
Condition acute cardiac failure
Classification by specialty
Cardiology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test a hypothesis that changes of body weight reflects clinical symptoms relating to acute cardiac failure.
Basic objectives2 Others
Basic objectives -Others To explore possible usefulness of vital signs obtained by load cells placed under the bed legs.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes clinical symptoms relating to acute cardiac failure at 48 hours after admission
Key secondary outcomes changes of body weight and other vital signs obtained by load cell signals under the bed legs

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Acute cardiac failure patients who have 2 or more than 2 major symptoms of Framingham criteria, and BNP 100 pg/ml at admission
2. Acute cardiac failure patients who have 1 major criteria and 2 or more than 2 minor Framingham criteria and BNP 100 pg/mi at admission.
Key exclusion criteria When load cells are unable to be placed under the bed legs
Target sample size 38

Research contact person
Name of lead principal investigator
1st name Azusa
Middle name
Last name Inada
Organization Chiba Emergency Medical Center
Division name Department of Anesthesiology
Zip code 261-0012
Address 3-32-1 Isobe, Mihama-ku, Chiba city
TEL 043-279-2211
Email azusa.inada@chiba-emc.jp

Public contact
Name of contact person
1st name Shiroh
Middle name Isono
Last name Isono
Organization Graduate School of Medicine, Chiba University
Division name Department of Anesthesiology
Zip code 260-8670
Address 1-8-1 Inohana-cho, Chuo-ku
TEL 043-222-7171
Homepage URL
Email shirohisono@yahoo.co.jp

Sponsor
Institute Chiba Emergency Medical Center, Department of Anesthesiology
Institute
Department

Funding Source
Organization Graduate School of Medicine, Chiba University, Department of Anesthesiology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Chiba Emergency Medical Center
Address 3-32-1 Isobe, Mihama-ku, Chiba
Tel 043-279-2211
Email r.ymzk12@pref.chiba.lg.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
2020 Year 01 Month 10 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
2019 Year 10 Month 03 Day
Date of IRB
2017 Year 05 Month 12 Day
Anticipated trial start date
2020 Year 01 Month 09 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In order to test a hypothesis that changes of body weight reflects changes of clinical symptoms relating to deterioration of chronic cardiac failure(primary parameter), change of body weight, respiration and other vital signs will be continuously observed by using four load cells placed under the bed legs without restricting patient's movements during stay in intensive care unit in patients with chronic heart failure acute hatred.

Management information
Registered date
2020 Year 01 Month 08 Day
Last modified on
2020 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044466

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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