UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quantitative assessment of fluid volume overload and congestion using field-portable bioelectrical impedance analyzer in hospitalized patients with acute decompensated heart failure
Title of the study (Brief title)	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	Koji Takagi
Organization	Nippon Medical School Musashikosugi Hospital
Division name	Department of Cardiovascular Medicine, Intensive Care Unit
Address	1-396 Kosugi-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL	044-733-5181
Email	kojitakagi@nms.ac.jp

Public contact
Name of contact person	Koji Takagi
Organization	Nippon Medical School Musashikosugi Hospital
Division name	Department of Cardiovascular Medicine, Intensive Care Unit
Address	1-396 Kosugi-cho, Nakahara-ku, Kawasaki, Kanagawa
TEL	044-733-5181
Homepage URL
Email	kojitakagi@nms.ac.jp

Sponsor
Institute	Nippon Medical School Musashikosugi Hospital
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 01 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030016