UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026119 |
|---|---|
| Receipt number | R000030016 |
| Scientific Title | Quantitative assessment of fluid volume overload and congestion using field-portable bioelectrical impedance analyzer in hospitalized patients with acute decompensated heart failure |
| Date of disclosure of the study information | 2017/02/14 |
| Last modified on | 2017/02/13 22:51:43 |
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Basic information
Public title
Quantitative assessment of fluid volume overload and congestion using field-portable bioelectrical impedance analyzer in hospitalized patients with acute decompensated heart failure
Acronym
Quantitative assessment of fluid volume overload and congestion using field-portable bioelectrical impedance analyzer in hospitalized patients with acute decompensated heart failure
Scientific Title
Quantitative assessment of fluid volume overload and congestion using field-portable bioelectrical impedance analyzer in hospitalized patients with acute decompensated heart failure
Scientific Title:Acronym
Quantitative assessment of fluid volume overload and congestion using field-portable bioelectrical impedance analyzer in hospitalized patients with acute decompensated heart failure
Region
| Japan |
Condition
Condition
Heart failure(HF)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between extracellular fluid volume measured by field-portable bioelectrical impedance analyzer and evaluated values of fluid volume overload and congestion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between extracellular fluid volume measured by field-portable bioelectrical impedance analyzer and dimension and/or respiratory variation in inferior vena cava measured by echocardiography
Key secondary outcomes
Relationship between extracellular fluid volume measured by field-portable bioelectrical impedance analyzer and clinical indicators of fluid volume overload and/or congestion : degree of distention of the neck veins, edema index, pulmonary artery wedge pressure measured by pulmonary artery catheterization, body weight, and so on
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
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Bioelectrical impedance analysis and echocardiography (10 days, once a day)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized acute heart failure patients with volume overload
Key exclusion criteria
1) Patients with unstable hemodynamics
2) Diagnosed as an atrial fibrillation at the time of admission
3) Patients with hypoalbuminemia less than 3 g/dL
4) Patients who have obvious infection include urinary-tract infection and pneumonia
5) Body temperature of 37.5 degrees Celsius or higher
6) Hemodialysis patients
7) Patients with hemofiltration or extracorporeal ultrafiltration (ECUM) or continuous hemodiafiltration (CHDF) and/or combination of them
8) History of amputation of an extremity
9) History of cardiac surgical treatment within 30 days
10) Patients with advanced hepatic insufficiency or advanced renal dysfunction or severe hematological disturbance or adrenalism and/or combination of them
11) Pacemaker patients
12) Patients who cannot sprawl in the supine position for a reason other than respiratory discomfort (e.g. for a reason of contracture, spasmus, bone fracture, and so on)
13) Height or weight measurement cannot be performed (weight measurement by using scale-bed is acceptable)
14) Patients who are or are likely to be pregnant, or hope to be pregnant
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Takagi |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Department of Cardiovascular Medicine, Intensive Care Unit
Zip code
Address
1-396 Kosugi-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL
044-733-5181
kojitakagi@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Takagi |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Department of Cardiovascular Medicine, Intensive Care Unit
Zip code
Address
1-396 Kosugi-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL
044-733-5181
Homepage URL
kojitakagi@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Musashikosugi Hospital
Institute
Department
Personal name
Funding Source
Organization
TERUMO Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 02 | Month | 14 | 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
| 2017 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 13 | Day |
Last modified on
| 2017 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030016
