UMIN-CTR Clinical Trial

Basic information
Public title	The effect of landiolol hydrochloride for primary lung cancer patients with tachyarrhythmia in the perioperative period
Acronym	The effect of landiolol hydrochloride for primary lung cancer patients with tachyarrhythmia in the perioperative period
Scientific Title	The effect of landiolol hydrochloride for primary lung cancer patients with tachyarrhythmia in the perioperative period
Scientific Title:Acronym	The effect of landiolol hydrochloride for primary lung cancer patients with tachyarrhythmia in the perioperative period
Region	Japan

Condition
Condition	Primary lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the shortening of administration of landiolol hydrochloride will suppress the perioperative of primary lung cancer patients with tachyarrhythmia
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To compare the tachyarrhythmia incidence up to postoperative 72 hours between landiolol hydrochloride administration group and the non-administration group
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	The landiolol hydrochloride of 0.005mg/kg/min is administered to a patient through a indwelling aortic catheter from commencing surgery to postoperative day1 with adjusting the landiolol hydrochloride administration rate according to maintain the heart rate 60 (to 80) times/ min (dose titration method)
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	70 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Including primary lung cancer patients who meet any one following conditions, a cardiac disease, bilobectomy with thoracotomy, lung resection with a bronchial formation or angiogenesis, lung resection with composite resection of organ around lung.
Key exclusion criteria	Patient corresponding to the contraindication of landiolol hydrochloride 1) Patients with cardiogenic shock 2) Patients with diabetic ketoacidosis or metabolic acidosis 3) Patients with auriculoventricular block(out of 2nd degree) or bradyarrhythmia including sick sinus syndrome 4)Patients with right cardiac failure from pulmonary hypertension 5) Patients with congestive cardiac failure 6) Patients with untreated phaeochromocytoma 7) Patients with a previous history of hypersensitivity to components of landiolol hydrochloride 8) Patients with bronchial asthma 9) Patient with sick sinus syndrome(Including a pacemaker implantation) 10) Patient who is pregnant woman also possibility of pregnancy or nursing mother 11) Patient who is judged as inappropriate by doctor in attendance
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yukitoshi Middle name Last name Satoh
Organization	Kitasato University School of Medicine
Division name	Department of Thoracic Surgery
Zip code	252-0374
Address	1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, 252-0374, Japan
TEL	042-778-8828
Email	ysatoh@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Yukitoshi Middle name Last name Satoh
Organization	Kitasato University School of Medicine
Division name	Department of Thoracic Surgery
Zip code	252-0374
Address	1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa, 252-0374, Japan
TEL	042-778-8828
Homepage URL
Email	ysatoh@med.kitasato-u.ac.jp

Sponsor
Institute	Department of Thoracic Surgery, Kitasato University
Institute
Department

Funding Source
Organization	Kitasato 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	Kitasato University Medical Ethics Organization
Address	1-15-1 Minami-ku Sagamihara Kanagawa
Tel	042-778-8273
Email	rinri-n@kitasato-u.ac.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	2016 Year 07 Month 06 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	Completed
Date of protocol fixation	2013 Year 12 Month 11 Day
Date of IRB	2013 Year 12 Month 11 Day
Anticipated trial start date	2016 Year 07 Month 05 Day
Last follow-up date	2019 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 06 Day
Last modified on	2020 Year 01 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026534