UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045617 |
|---|---|
| Receipt number | R000048974 |
| Scientific Title | Worsening right ventricular function during cardiac surgery is a strong predictor of postoperative acute kidney injury: A prospective observational study |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2021/09/30 16:56:05 |
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Basic information
Public title
A study of between left and right ventricular systolic function by 3D-transesophageal echocardiography in patients undergoing cardiac surgery,
Acronym
A changes of left and right ventricular function during cardiac surgery
Scientific Title
Worsening right ventricular function during cardiac surgery is a strong predictor of postoperative acute kidney injury: A prospective observational study
Scientific Title:Acronym
Worsening right ventricular function during cardiac surgery is a strong predictor of postoperative acute kidney injury
Region
| Japan |
Condition
Condition
Right ventricular dysfunction, acute kidney injury
Classification by specialty
| Cardiology | Nephrology | Cardiovascular surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether changes of intraoperative right ventricular function were related with cardiac surgery-associated acute kidney injury (CSA-AKI).
Basic objectives2
Others
Basic objectives -Others
To investigate which is the most related to renal function after cardiac surgery in right ventricular parameters.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum creatinine values at preoperative and postoperative period
Key secondary outcomes
Cardiac catheterization, and echocardiographic right ventricular (RV) and left ventricular function parameters were measured simultaneously before and after CPB.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
From August 2019 to the end of August 2020, we will continuously target patients who are scheduled to undergo the first open heart surgery under cardiopulmonary bypass or cardiac arrest at our facility.
Key exclusion criteria
Preoperative exclusion criteria
1) Moderate or severe tricuspid regurgitation / Right heart surgery
2) On beating surgery
3) Scheduled intraoperative assisted circulation use (VA-ECMO, IABP, LVAD)
4) Pacemaker
5) Chronic atrial fibrillation
6) Complication of left-right short-circuit disease
7) Abnormal regional wall motion
8) Contraindications for 3DE and PAC (pulmonary artery catheter) insertion
Intraoperative exclusion criteria
1) Use of pacemaker due to sinus node syndrome, atrioventricular block during surgery,
2) Atrial fibrillation during surgery
3) Addition of tricuspid valve surgery, change to surgery on beating, off-pump surgery
4) Use of auxiliary circulation after withdrawal from the heart-lung machine
5) Cannot be monitored by three-dimensional transesophageal echocardiography or pulmonary artery catheter
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Yasuaki |
| Middle name | |
| Last name | Tohi |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
TEL
022-717-7321
dopinxp@gmail.com
Public contact
Name of contact person
| 1st name | Yasuaki |
| Middle name | |
| Last name | Tohi |
Organization
Tohoku University School of Medicine
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
TEL
022-717-7321
Homepage URL
dopinxp@gmail.com
Sponsor or person
Institute
Tohoku University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Tohoku University, School of Medicine
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi
Tel
022-717-7321
dopinxp@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | 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
34
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 02 | Month | 01 | Day |
Other
Other related information
We will enroll cases continuously from the start date of enrollment, and will end after one year.
Management information
Registered date
| 2021 | Year | 09 | Month | 30 | Day |
Last modified on
| 2021 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048974
