UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039088 |
|---|---|
| Receipt number | 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 16:42:16 |
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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
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
shirohisono@yahoo.co.jp
Sponsor or person
Institute
Chiba Emergency Medical Center, Department of Anesthesiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044466
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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