UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019312 |
|---|---|
| Receipt number | R000022302 |
| Scientific Title | Hemodynamic Monitoring by FloTrac Sensor in Patients with Acute Congestive Heart Failure |
| Date of disclosure of the study information | 2015/10/14 |
| Last modified on | 2022/04/16 10:03:27 |
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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
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
yooouyou@gmail.com
Sponsor or person
Institute
Mitsui Memorial Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022302
