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Nifekalant Versus Amiodarone in New-Onset Atrial Fibrillation After Cardiac Surgery

Nifekalant Versus Amiodarone in New-Onset Atrial Fibrillation After Cardiac Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058655
Enrollment
Unknown
Registered
2022-04-13
Start date
2022-04-30
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

New-Onset Atrial Fibrillation After Cardiac Surgery

Interventions

Nifekalant arm:Nifekalant
Amiodarone arm:Amiodarone

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old, 1 minute, and 90/MAP>60mmHg); 5. 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; 6. Obtained the informed consent from the patients or their family members.

Exclusion criteria

Exclusion criteria: 1. Heart transplantation, left heart assist device (LVAD) or extracorporeal membrane oxygenation (ECMO) treatment; 2. History of atrial fibrillation/atrial flutter and a history of paroxysmal supraventricular tachycardia; 3. Radiofrequency ablation; 4. Rheumatic heart disease; 5. Complex congenital heart disease (with more than two coexisting congenital heart defects); 6. Cardiac tumors; 7. Transcatheter aortic valve implantation (TAVI), transcatheter mitral valve intervention (TMVI), and transcatheter tricuspid valve intervention (TTVI); 8. 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); 9. Heart rate (HR) 140ms without a pacemaker; 10. Received amiodarone or nifekalant within 6 weeks before the operation; 11. Pregnant and lactating female patients; 12. Uncorrected hypokalemia (serum potassium <3.5mmol/L) or hypomagnesemia (whole blood/serum magnesium below the lower limit); 13. Chronic renal failure and/or continuous renal replacement therapy (CRRT); 14. Return to OR during ICU stay or readmission to ICU from Cardiac Surgery ward; 15. Other factors not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Rate of cardioversion at 4 hours;

Secondary

MeasureTime frame
Rate of cardioversion at 90 minutes;Rate of cardioversion at 24 hours;Maintenance time of sinus rhythm within 24 hours;Average time to AF conversion to sinus rhythm;

Countries

China

Contacts

Public ContactXiaotong Hou

Beijing Anzhen Hospital, Capital Medical University

xt.hou@ccmu.edu.cn+86 010-64456631

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026