UMIN-CTR Clinical Trial

Basic information
Public title	Effect of low-dose landiolol on hemodynamics in patients with left ventricular dysfunction undergoing off-pump cononary artery bypass grafting surgery: A retrospective study
Acronym	Effect of low-dose landiolol on hemodynamics in patients undergoing OPCAB
Scientific Title	Effect of low-dose landiolol on hemodynamics in patients with left ventricular dysfunction undergoing off-pump cononary artery bypass grafting surgery: A retrospective study
Scientific Title:Acronym	Effect of low-dose landiolol on hemodynamics in patients undergoing OPCAB
Region	Japan

Condition
Condition	ischemic heart disease
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will evaluate the effect of landiolol on hemodynamics in patients with left ventricular dysfunction undergoing off-pump cononary artery bypass grafting surgery
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	heart rate
Key secondary outcomes	systolic blood pressure, diastolic blood pressure, stroke volume index, mixed venous oxygen saturation

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	patients in which landiolol was administered during OPCAB surgery
Key exclusion criteria	patients who were under an implanted or temporary pacemaker, and who were defibrillated during the operation were excluded
Target sample size	38

Research contact person
Name of lead principal investigator	1st name Katsuhiro Middle name Last name Seo
Organization	Kokura Memorial Hospital
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	802-8555
Address	3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka
TEL	0935112000
Email	seo-k@kokurakinen.or.jp

Public contact
Name of contact person	1st name Junya Middle name Last name Kuribayashi
Organization	Kokura Memorial Hospital
Division name	Department of Anesthesiology and Intensive Care Medicine
Zip code	802-8555
Address	3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka
TEL	0935112000
Homepage URL
Email	j_kuriba0416@yahoo.co.jp

Sponsor
Institute	Kokura Memorial Hospital
Institute
Department

Funding Source
Organization	Kokura 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	Kokura Memorial Hospital
Address	3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka
Tel	0935112000
Email	rinsyo@kokurakinen.or.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	2020 Year 12 Month 21 Day

Related information
URL releasing protocol	http://www.kokurakinen.or.jp/bumon/rinsyoukenkyu/ippan/pdf/ippan-05-02.pdf
Publication of results	Unpublished

Result
URL related to results and publications	https://nsas.anesth.or.jp/App/Datura/sm/61/session/P2-23.html#P2-23-6
Number of participants that the trial has enrolled	55
Results	In OPCAB surgery, low-dose landiolol was used and reduced HR with decreased SAP regardless of preoperative EF. The lower value of DAP in low EF patients may have been attributed to the demographic higher incidence of intra-aortic balloon pumping.
Results date posted	2020 Year 11 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	patients in which landiolol was administered during OPCAB surgery
Participant flow	We retrospectively reviewed the anesthesia records
Adverse events	None
Outcome measures	heart rate, systolic blood pressure, diastolic blood pressure, cardiac index, stroke volume index, mixed venous oxygen saturation
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 01 Day
Date of IRB	2014 Year 12 Month 01 Day
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date	2013 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	we retrospectively reviewed the relevant anesthesia records in our hospital about the hemodynamic parameters

Management information
Registered date	2020 Year 12 Month 21 Day
Last modified on	2020 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048398