UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of Landiolol Administration for Prevention of Atrial Fibrillation after Proximal Aortic Surgery
Acronym	Landiolol administration for POAF
Scientific Title	Landiolol for Prevention of Atrial Fibrillation after Proximal Aortic Surgery
Scientific Title:Acronym	Landiolol for POAF after proximal aortic surgery
Region	Japan

Condition
Condition	the aneurysm of aortic root, ascending aorta, or aortic arch/the dissection of proximal aorta
Classification by specialty	Cardiology Anesthesiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	reduction of the incidence of new-onset postoperative atrial fibrillation (POAF)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	reduction of the incidence of new-onset POAF that occurred within 72 hrs after operation
Key secondary outcomes	30-day mortality, 30-day symptomatic cerebral infarction, length of hospital stay (days), length of ICU stay (days), length of mechanical ventilation (hours), need for pacemaker support (using pacemaker for stability of hemodynamics), and average of mean BP and HR during 72 hrs after ICU admission

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	100 years-old >
Gender	Male and Female
Key inclusion criteria	patients more than 18 years old without preoperative AF who underwent proximal aortic surgery at Hiroshima City Hospital between January 1, 2011, and December 31, 2018
Key exclusion criteria	preoperative AF CABG or valve surgery performed with aortic surgery missing data
Target sample size	250

Research contact person
Name of lead principal investigator	1st name jun Middle name Last name kaminohara
Organization	Kokura memorial hospital
Division name	Department of anesthesiology
Zip code	8028555
Address	3-2-1, Asano, Kitakyushu Kokurakita-ku, Fukuoka
TEL	093-511-2000
Email	stujunjun1031@yahoo.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Takatori
Organization	Hiroshima City Hospital
Division name	Department of Anesthesia and Intensive care
Zip code	7308518
Address	7-33, Motomachi, Hiroshima Naka Ku, Hiroshima
TEL	082-221-2291
Homepage URL
Email	takatori@ksj.biglobe.ne.jp

Sponsor
Institute	Hiroshima city hospital
Institute
Department

Funding Source
Organization	No funding
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	Hiroshima City Hospital
Address	Department of Anesthesia and Intensive care
Tel	082-221-2291
Email	stujunjun1031@yahoo.co.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	広島市立広島市民病院

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 22 Day

Related information
URL releasing protocol	http://www.city-hosp.naka.hiroshima.jp/guide/info/activity_2.php
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	264
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 04 Month 10 Day
Date of IRB	2019 Year 05 Month 16 Day
Anticipated trial start date	2019 Year 04 Month 11 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We retrospectively collected pre- and peri-operative patients' data shown in Tables from the patient records.

Management information
Registered date	2021 Year 03 Month 22 Day
Last modified on	2021 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049889