UMIN-CTR Clinical Trial

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
Email	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
Email	dopinxp@gmail.com

Sponsor
Institute	Tohoku University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048974