Nifekalant Versus Amiodarone in New-Onset Atrial Fibrillation After Cardiac Surgery
New Onset Atrial Fibrillation, Complications; Cardiac, Postoperative
About this trial
This is an interventional treatment trial for New Onset Atrial Fibrillation focused on measuring Nifekalant, Amiodarone, Cardiac Surgery, Postoperative Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years old, <85 years old, no gender limit;
- Postoperative atrial fibrillation in the ICU after cardiac surgery;
- The duration of atrial fibrillation> 1 minute, and ≤ 48 hours;
- Hemodynamically stable (no need to increase vasoactive drugs and SBP>90/MAP>60mmHg);
- After pre-treatment (including: correcting electrolyte disturbances, optimizing volume status, improving oxygenation, controlling body temperature, analgesia and minimizing the use of inotropes and vasopressors), the clinician believes that antiarrhythmic drugs are needed.
- Obtained the informed consent from the patients or their family members.
Exclusion Criteria:
- Heart transplantation, left heart assist device (LVAD) or extracorporeal membrane oxygenation (ECMO) treatment;
- History of atrial fibrillation/atrial flutter and a history of paroxysmal supraventricular tachycardia;
- Radiofrequency ablation;
- Rheumatic heart disease;
- Complex congenital heart disease (with more than two coexisting congenital heart defects);
- Cardiac tumors;
- Transcatheter aortic valve implantation (TAVI), transcatheter mitral valve intervention (TMVI), and transcatheter tricuspid valve intervention (TTVI);
- Contraindications to amiodarone/nifekalant (PR interval>240ms; 2nd or 3rd degree atrioventricular block (AVB); QT>440ms; familial long QT syndrome; Untreated thyroid disease; AST or ALT>2 times the upper limit; liver cirrhosis; interstitial lung disease);
- Heart rate (HR) <50 beats/min and/or QRS>140ms without a pacemaker;
- Received amiodarone or nifekalant within 6 weeks before the operation;
- Pregnant and lactating female patients;
- Uncorrected hypokalemia (serum potassium <3.5mmol/L) or hypomagnesemia (whole blood/serum magnesium below the lower limit);
- Chronic renal failure and/or continuous renal replacement therapy (CRRT);
- Return to OR during ICU stay or readmission to ICU from Cardiac Surgery ward.
- Other factors not suitable for participating in this study
Sites / Locations
- Beijing Anzhen HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intravenous Nifekalant
Intravenous Amiodarone
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.
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.