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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010653
Receipt No. R000012416
Scientific Title The effect of Landiolol hydrochloride administrated in the perioperative period of off-pump coronary artery bypass graft surgery on prevention of atrial fibrillation or atrial flutter
Date of disclosure of the study information 2013/05/07
Last modified on 2018/10/05

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Basic information
Public title The effect of Landiolol hydrochloride administrated in the perioperative period of off-pump coronary artery bypass graft surgery on prevention of atrial fibrillation or atrial flutter
Acronym JL-KNIGHT study II (Japan Landiolol-Kicking off the novel investigation for gold standard heart study II)
Scientific Title The effect of Landiolol hydrochloride administrated in the perioperative period of off-pump coronary artery bypass graft surgery on prevention of atrial fibrillation or atrial flutter
Scientific Title:Acronym JL-KNIGHT study II (Japan Landiolol-Kicking off the novel investigation for gold standard heart study II)
Region
Japan

Condition
Condition Patients undergoing off-pump coronary artery bypass graft surgery (CABG)
Classification by specialty
Cardiology Anesthesiology Cardiovascular surgery
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of the perioperative intravenous administration of short-acting beta 1-adrenergic receptor antagonist, Landiolol hydrochloride on the prevention of atrial fibrillation or atrial flutter in the postoperative period of off-pump coronary artery bypass graft surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Number of patients with atrial fibrillation or atrial flutter persisting for more than 1 minute in 6 days after surgery
Key secondary outcomes -Number of patients with atrial fibrillation or atrial flutter in 6 days after surgery
-Heart rate and blood pressure
-Length of stay in intensive care unit after surgery
-Length of stay at hospital after surgery
-In-hospital medical expense after surgery
-Plasma level of brain natriuretic peptide (BNP) or N-terminal prohormone of BNP (NT-proBNP)
-Number of patients with major adverse cerebral and cardiovascular events
-Extent of cerebral infarction evaluated by brain magnetic resonance imaging (MRI)
-Visual analogue scale (VAS) score for subjective assessment of anastomosis during surgical operation
-Motion analysis of anastomotic part of coronary artery
-Evaluation of coronary artery bypass graft patency by angiography

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Each subject will be administered Landiolol intravenously at a rate of 3 micrograms/kg/min (0.06 mL/kg/hr) just after anesthetic induction. Heart rate should be maintained at a level between 50 and 80 bpm. The infusion rate of Landiolol can be increased by a rate of 1 microgram/kg/min (0.02 mL/kg/hr) when heart rate is over 80 bpm for 15 or 20 minutes and decreased by a rate of 0.5-1 micrograms/kg/min (0.01-0.02 mL/kg/hr) when the heart rate obviously tend to decrease even within the target heart rate (50-80 bpm). Infusion of Landiolol should be maintained within a rate of 0.5-20 micrograms/kg/min (0.01-0.4 mL/kg/hr) for 24 hours. Medical treatment using atropine or ephedrine etc. or pacing therapy will be performed when heart rate is under 50 bpm, however infusion of Landiolol has to be maintained with minimum rate (0.5 micrograms/kg/min (0.01 mL/kg/hr)) under such condition.
Interventions/Control_2 Each subject will be administered saline intravenously at a rate of 0.06 mL/kg/hr just after anesthetic induction. Heart rate should be maintained at a level between 50 and 80 bpm. The infusion rate of saline can be increased by a rate of 0.02 mL/kg/hr when heart rate is over 80 bpm for 15 or 20 minutes and decreased by a rate of 0.01-0.02 mL/kg/hr when the heart rate obviously tend to decrease even within the target heart rate (50-80 bpm). Infusion of saline should be maintained within a rate of 0.01-0.4 mL/kg/hr for 24 hours. Medical treatment using atropine or ephedrine etc. or pacing therapy will be performed when heart rate is under 50 bpm, however infusion of saline has to be maintained with minimum rate (0.01 mL/kg/hr) under such condition.
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with written informed consent
2) Patients aged from 20 to 85 years old
3) Patients who are going to have first CABG surgery
Key exclusion criteria 1) Patients with acute myocardial infarction occurred within 3 days after getting informed consent
2) Patients with history of atrial fibrillation or atrial flutter (including paroxysmal atrial fibrillation or atrial flutter)
3) Patients who will have any emergency operations within 24 hours after the hospital visits
4) Patients with cardiac shock
5) Patients with diabetic keto-acidosis or metabolic acidosis
6) Patients with bradyarrhythmias (sick sinus syndrome or second or third degree atrioventricular block)
7) Patients with pulmonary arterial hypertension complicating right heart failure
8) Patients with severe heart failure (NYHA functional classification is greater than grade three or ejection fraction is less than 35%)
9) Patients or suspected persons with untreated pheochromocytoma
10) Pregnant women or women with breast-feeding or patients who have possibilities of pregnancy
11) Patients with bronchial asthma or chronic lung diseases
12) Patients with past history of drug hypersensitivity against Landiolol
13) Patients who are judged by the investigators to be inappropriate for this study
Target sample size 520

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsuhiro Sakamoto
Organization Nippon Medical School
Division name Department of Anesthesiology
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8602 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsuhiro Sakamoto
Organization Nippon Medical School
Division name Department of Anesthesiology
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8602 JAPAN
TEL 03-3822-2131
Homepage URL http://jlknight.net/
Email

Sponsor
Institute The Society of Clinical Peri-operative Circulation Management
Institute
Department

Funding Source
Organization Japan Heart Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 05 Month 07 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 04 Month 16 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 07 Day
Last modified on
2018 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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