UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052055 |
|---|---|
| Receipt number | R000059231 |
| Scientific Title | Evaluation of optimal stress tests and hemodynamic parameters in successful weaning from extracorporeal mechanical circulatory support |
| Date of disclosure of the study information | 2023/08/30 |
| Last modified on | 2024/08/14 13:45:35 |
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Basic information
Public title
Evaluation of optimal stress tests and hemodynamic parameters in successful weaning from extracorporeal mechanical circulatory support
Acronym
OUTPUT study
Scientific Title
Evaluation of optimal stress tests and hemodynamic parameters in successful weaning from extracorporeal mechanical circulatory support
Scientific Title:Acronym
OUTPUT study
Region
| Japan |
Condition
Condition
Patients who require extracorporeal mechanical circulatory support due to cardiogenic shock or advanced heart failure.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the optimal stress tests and hemodynamic parameters in successful weaning from extracorporeal mechanical circulatory support.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Successful weaning from extracorporeal mechanical circulatory support
Key secondary outcomes
Death (cardiovascular and non-cardiovascular), heart failure, re-introduction of mechanical circulatory support, fatal arrhythmia, cerebral hemorrhage, embolism, major bleeding requiring transfusion, lower extremity ischemia.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who require extracorporeal mechanical circulatory support due to cardiogenic shock or advanced heart failure.
Key exclusion criteria
Patients who were introduced extracorporeal mechanical circulatory support for cardiac surgery or catheter intervention. Patients with congenital heart disease or cardiac shunt.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
81-263-37-3486
jersey0042@gmail.com
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Suzuki |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
81-263-37-3486
Homepage URL
jersey0042@gmail.com
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinshu University Institutional Review Board
Address
3-1-1 Asahi, Matsumoto, Japan
Tel
81-263-37-2572
mdrinri@shinshu-u.ac.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
| 2023 | Year | 08 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2028 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059231
