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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

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 - JL-KNIGHT study II (Japan Landiolol-Kicking off the novel investigation for gold standard heart study II)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010653
Enrollment
520
Registered
2013-05-07
Start date
2013-09-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing off-pump coronary artery bypass graft surgery (CABG)

Interventions

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

Sponsors

The Society of Clinical Peri-operative Circulation Management
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Number of patients with atrial fibrillation or atrial flutter persisting for more than 1 minute in 6 days after surgery

Secondary

MeasureTime frame
-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

Countries

Japan

Contacts

Public ContactAtsuhiro Sakamoto

Nippon Medical School Department of Anesthesiology

03-3822-2131

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026