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Postoperative atrial fibrillation is a major complication of cardiac surgery, which could lead to high morbidity and mortality, increase duration of hospital stay and increase the cost of treatment. New-onset atrial fibrillation after cardiac surgery is considered as a multifactorial phenomenon. Amiodarone, the most commonly used drug for cardioversion, is limited in atrial fibrillation after cardiac surgery due to side effects such as hypotension, bradycardia, and extracardiac side effects. Nifekalant is a novel class III antiarrhythmic agent with short onset time. It is a pure potassium channel blocker, which generally does not cause hypotension and bradycardia. There have been several trials that proven efficacy of nifekalant in converting persistent atrial fibrillation. For atrial fibrillation after cardiac surgery, the effectiveness and safety of nifekalant compared to amiodarone have not yet been reported. The investigators plan to perform a clinical trial comparing nifekalant to amiodarone in new-onset atrial fibrillation after cardiac surgery patients with a primary outcome of cardioversion at 4 hours. Secondary outcomes will follow cardioversion at 90 minutes and 24 hours, maintenance time of sinus rhythm within 24 hours, average time to conversion to sinus rhythm, rate of hypotension, length of ICU stay, length of hospital stay and hospital mortality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Nifekalant | Experimental | Patients randomized to Nifekalant arm will receive a bolus of 0.3mg/kg IV in the first 5 minutes and a maintenance dose of 0.2-0.4mg/kg/h for 24 hours. If the patient has a recurrence of atrial fibrillation, the maintenance dose can be increased (up to 0.8 mg/kg/h) according to the patient's condition, or receive a bolus of 3mg/kg again at 2 hours intervals. Nifekalant is administered for 24 hours unless meeting the criteria for discontinuation. |
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| Intravenous Amiodarone | Active Comparator | Patients randomized to an amiodarone arm will receive a bolus of 150mg IV in the first 10 minutes and a maintenance dose of 0.5-1mg/min for 24 hours. If the patient has a recurrence of atrial fibrillation, the dosage can be adjusted according to the patient's condition, but the total dosage administered within 24 hours should not exceed 2g. Amiodarone is administered for 24 hours unless meeting the criteria for discontinuation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifekalant | Drug | Patients identified with new-onset atrial fibrillation with a sustained duration of greater than 1 minutes and less than 48 hours will be considered for the study. Patients randomized to nifekalant arm will receive a bolus of 0.3mg/kg IV in the first 5 minutes and a maintenance dose of 0.2-0.4mg/kg/h for 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cardioversion at 4 hours | Rate of cardioversion of new-onset atrial fibrillation at 4 hours. The rate of cardioversion = the number of patients who meet the cardioversion criteria in the group / the total number of patients in the group × 100%. Cardioversion criteria is: atrial fibrillation stops at least once during the 24 hours observation period and lasts for more than 1 minute. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cardioversion at 90 minutes | Rate of cardioversion of new-onset atrial fibrillation at 90minutes. The rate of cardioversion = the number of cases who meet the cardioversion criteria in the group / the total number of cases in the group × 100%. | 90 minutes |
| Rate of cardioversion at 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaotong Hou, MD, PhD | Contact | +8610 64456631 | xt.hou@ccmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaotong Hou, MD, PhD | Beijing Anzhen Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| C076259 | nifekalant |
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Amiodarone | Drug | Patients identified with new-onset atrial fibrillation with a sustained duration of greater than 1 minutes and less than 48 hours will be considered for the study. Patients randomized to amiodarone arm will receive a bolus of 150mg IV in the first 10 minutes and a maintenance dose of 0.5-1mg/min for 24 hours. |
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Rate of cardioversion of new-onset atrial fibrillation at 24 hours. The rate of cardioversion = the number of patients who meet the cardioversion criteria in the group / the total number of patients in the group × 100%. |
| 24 hours |
| Maintenance time of sinus rhythm within 24 hours | The total duration of sinus rhythm within 24 hours. | 24 hours |
| Average time to AF conversion to sinus rhythm | Average time from administration of drugs to cardioversion to sinus rhythm. | 24 hours |
| The incidence of hypotension | "Hypotension" is defined as: SBP <85mmHg for more than 5 minutes or increase of vasoactive drugs. Incidence = number of cases of hypotension / total number of cases in this group × 100%. | 24 hours |
| Vasoactive Inotropic Score (VIS) at 90 minutes, 4 hours, and 24 hours | VIS= Dopamine (ug/kg/min) + dobutamine (ug/kg/min) + 100×adrenaline (ug/kg/min) + 50×levosimendan (ug/kg/min) + 10× milrinone (ug/kg/min) + 10000× vasopressin (unit/kg/min) + 100×norepinephrine (ug/kg/min). | 24 hours |
| Incidence of severe bradycardia, 3rd degree AVB, severe ventricular arrhythmia | Severe ventricular arrhythmia: polymorphic/persistent ventricular tachycardia, torsade de pointes (Tdp), ventricular fibrillation. Incidence = number of cases of severe bradycardia, 3rd degree AVB, severe ventricular arrhythmia / total number of cases in this group × 100%. | 24 hours |
| Liver and kidney function within 24 hours | Indicators of liver function include ALT and AST. Indicator of kidney function is serum creatinine (Scr). | 24 hours |
| Cardiac function | Indicator of cardiac function is left ventricular ejection fraction (LVEF) assessed with echocardiography. | 24 hours |
| Adverse events | Adverse medical events that occur after a patient receives a drug, but it does not necessarily have a causal relationship with the treatment. | 24 hours |
| Co-administration of drugs | Including patients' basic medications and medications co-administrated during research. | 24 hours |
| Length of ICU stay | Days of patients' stay in ICU | up to 6 months |
| Days of hospital stay | Days of patients' stay in hospital | up to 6 months |
| Hospital mortality | Mortality of patients during hospitalization | up to 6 months |