UMIN-CTR Clinical Trial

Basic information
Public title	Perioperative landiolol hydrochloride for preventing of atrial fibrillation after lung resection
Acronym	Perioperative landiolol hydrochloride for preventing of atrial fibrillation after lung resection
Scientific Title	Perioperative landiolol hydrochloride for preventing of atrial fibrillation after lung resection
Scientific Title:Acronym	Perioperative landiolol hydrochloride for preventing of atrial fibrillation after lung resection
Region	Japan

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

Objectives
Narrative objectives1	Does Landiolol Hydrochloride decrease the incidence of atrial fiblillation after lung resection?
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	the frequency of atrial fibrillation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intravenous prasebo, Glucose 5% during operation.
Interventions/Control_2	Intravenous landiolol hydrochloride during the operation.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	patients who have lung cancer, to be treated by pnemonectomy or bilbectomy.
Key exclusion criteria	(1) patients without previous or current cardiovascular history (2) bradycardia (3) superventricular arrhythmia (4) significant alteration of atrioventricular conduction Patients with sick sinus syndromr Patients with chronic inflammatory disease Patients with moderate - severe valvular disease Patients with significant liver failure Patients with significant renal failure
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Atsuhiro Middle name Last name Sakamoto
Organization	Nippon Medical School
Division name	Department of Anesthesiology
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL	0338222131
Email	fuku-kaori@nms.ac.jp

Public contact
Name of contact person	1st name Yagi Middle name Last name Kaori
Organization	Nippon Medical School
Division name	Department of Anesthesiolgy
Zip code	113-8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo 113-8602, Japan
TEL	0338222131
Homepage URL
Email	fuku-kaori@nms.ac.jp

Sponsor
Institute	Nippon Medical School Department of Anesthesiolgy
Institute
Department

Funding Source
Organization	Nippon Medical School Department of Anesthesiolgy
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	Nippon Medical School
Address	1-1-5, Sendagi Bunkyou-ku
Tel	03-3822-2131
Email	clinicaltrial@nms.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	2012 Year 04 Month 01 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	Enrolling by invitation
Date of protocol fixation	2011 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date	2011 Year 07 Month 01 Day
Last follow-up date	2014 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 01 Month 01 Day
Date trial data considered complete	2016 Year 07 Month 01 Day
Date analysis concluded	2016 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date	2012 Year 03 Month 23 Day
Last modified on	2022 Year 10 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006764