UMIN-CTR Clinical Trial

Basic information
Public title	Hemodynamic Monitoring by FloTrac Sensor in Patients with Acute Congestive Heart Failure
Acronym	Hemodynamic Monitoring by FloTrac Sensor in Patients with ACHF
Scientific Title	Hemodynamic Monitoring by FloTrac Sensor in Patients with Acute Congestive Heart Failure
Scientific Title:Acronym	Hemodynamic Monitoring by FloTrac Sensor in Patients with ACHF
Region	Japan

Condition
Condition	Acute Congestive Heart Failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to investigate the usefulness of FloTrac Sensor in hemodynamic monitoring in patients with acute congestive heart failure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The correlation between hemodynamic data calculated by FloTrac Sensor (cardiac out put, peripheral vascular resistance, and stroke volume variation) and physical findings, and the correlation between hemodynamic data calculated by FloTrac Sensor and those data calculated by echocardiography.
Key secondary outcomes	Short term outcome: in-hospital death, acute renal failure, length of CCU stay, and length of hospital stay. Long term outcome: left ventricular end systolic volume index and brain natriuretic peptide level at 12 months.

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	To utilize FroTrac Sensor for hemodynamic monitoring.
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	Patients with acute congestive heart failure who admitted to the coronary care unit.
Key exclusion criteria	Patients with acute coronary syndrome Patients treated with intra abdominal balloon pump or extracorporeal membrane oxygenation Patients with severe aortic valve regurgitation Patients with atrial fibrilation or flutter Patients who refused enrollment
Target sample size	17

Research contact person
Name of lead principal investigator	1st name Kengo Middle name Last name Tanabe
Organization	Mitsui Memorial Hospital
Division name	Division of Cardiology
Zip code	101-8643
Address	Kanda-Izumi-Cho 1, Chiyoda-ku, Tokyo 101-8643
TEL	0338629111
Email	kengo-t@zd5.so-net.ne.jp

Public contact
Name of contact person	1st name Yu Middle name Last name Horiuchi
Organization	Mitsui Memorial Hospital
Division name	Division of Cardiology
Zip code	101-8643
Address	Kanda-Izumi-Cho 1, Chiyoda-ku, Tokyo 101-8643
TEL	0338629111
Homepage URL
Email	yooouyou@gmail.com

Sponsor
Institute	Mitsui Memorial Hospital
Institute
Department

Funding Source
Organization	Mitsui Memorial Hospital
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	Mitsui Memorial Hospital
Address	Kanda-Izumi-Cho 1, Chiyoda-ku, Tokyo
Tel	0338629111
Email	yooouyou@gmail.com

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	三井記念病院

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 14 Day

Related information
URL releasing protocol	NA
Publication of results	Unpublished

Result
URL related to results and publications	NA
Number of participants that the trial has enrolled	17
Results	NA
Results date posted	2022 Year 04 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	NA
Participant flow	NA
Adverse events	NA
Outcome measures	NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 25 Day
Date of IRB	2015 Year 08 Month 10 Day
Anticipated trial start date	2015 Year 10 Month 14 Day
Last follow-up date	2016 Year 08 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 11 Day
Last modified on	2022 Year 04 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022302