UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055720 |
|---|---|
| Receipt number | R000063087 |
| Scientific Title | Investigation of the usefulness of mitral annulus velocity as a predictor of successful weaning from cardiopulmonary bypass in cardiac surgery. |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2024/12/26 17:36:50 |
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Basic information
Public title
Investigation of the usefulness of mitral annulus velocity as a predictor of successful weaning from cardiopulmonary bypass in cardiac surgery.
Acronym
Investigation of the usefulness of mitral annulus velocity as a predictor of successful weaning from cardiopulmonary bypass in cardiac surgery.
Scientific Title
Investigation of the usefulness of mitral annulus velocity as a predictor of successful weaning from cardiopulmonary bypass in cardiac surgery.
Scientific Title:Acronym
Investigation of the usefulness of mitral annulus velocity as a predictor of successful weaning from cardiopulmonary bypass in cardiac surgery.
Region
| Japan |
Condition
Condition
Coronary Artery Disease, Valvular Heart Disease
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to perform receiver operating characteristic (ROC) analysis to determine the appropriate cutoff value for the mitral annular velocity immediately before the start of weaning from cardiopulmonary bypass, with a particular focus on the early diastolic velocity, to predict successful weaning from cardiopulmonary bypass. The purpose of this study is to create an index for the initiation of weaning from cardiopulmonary bypass that did not previously exist, and to contribute to the improvement of the safety of cardiac surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Create a ROC curve that predicts successful weaning from the cardiopulmonary bypass for mitral annulus velocity and find the optimal cutoff value.
Key secondary outcomes
Perform multivariate logistic regression analysis to determine whether preoperative echocardiographic values, aortic cross clamping and dose of inotropic and vasoconstrictive drugs are associated with successful weaning from cardiopulmonary bypass. Multivariate linear regression analysis of factors affecting mitral annulus velocity.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled to undergo cardiac arrest during cardiopulmonary bypass for valvular heart surgery or coronary artery bypass surgery
Key exclusion criteria
1) Patients with a history of constrictive pericarditis
2) Patients with congenital heart disease
3) Patients undergoing surgery on the thoracic aorta at the same time
4) Patients who have not had an echocardiogram before surgery
5) Patients with contraindications to transesophageal echocardiography
6) Patients who required a second cardiopulmonary bypass due to complications after the first
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Suda |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan.
TEL
0166-68-2583
kyokui110025@gmail.com
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Suda |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan.
TEL
0166-68-2583
Homepage URL
kyokui110025@gmail.com
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
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
Asahikawa Medical University
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido, Japan.
Tel
0166-68-2583
kyokui110025@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
旭川医科大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 07 | 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
| 2024 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted from October 7, 2024 to September 30, 2026.
Data will be collected using transesophageal echocardiography before the weaning of cardiopulmonary bypass in cardiac surgery.
Patients will be explained using a patient information sheet approved by the research ethics.
Management information
Registered date
| 2024 | Year | 10 | Month | 03 | Day |
Last modified on
| 2024 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063087
