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Perioperative intravenous amiodarone for prevention of new-onset atrial fibrillation after coronary artery bypass

Perioperative intravenous amiodarone for prevention of new-onset atrial fibrillation after coronary artery bypass

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054587
Enrollment
Unknown
Registered
2021-12-20
Start date
2021-12-24
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

new-onset atrial fibrillation

Interventions

Control group:5% glucose solution

Sponsors

Fuwai Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged>= 18 years; 2. Accept elective cardiopulmonary bypass coronary artery bypass grafting; 3. Sinus rhythm; 4. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with poor compliance, or patients who cannot complete long-term follow-up, or patients who have not received elective CPB coronary artery bypass grafting; 2. History of atrial fibrillation or amiodarone treatment within half a year before surgery; 3. History of arrhythmia or taking antiarrhythmic drugs other than beta-blockers or calcium channel blockers within half a year before surgery; 4. Allergic to iodine, amiodarone or its excipients; 5. Patients with implanted cardioverter-defibrillator or pacemaker; 6. Thyroid dysfunction; 7. Liver insufficiency (alanine aminotransferase or aspartate aminotransferase higher than 2 times the upper limit of normal); 8. Renal insufficiency (serum creatinine greater than 200 µmol/L); 9. Pulmonary fibrosis; 10. Corneal disease or severe vision loss or blindness; 11. The last blood potassium level before surgery is less than 3.5mmol/L; 12. Patients with definite diagnosis of severe valve disease, congenital heart disease or macrovascular disease who need other types of cardiac surgery except coronary artery bypass grafting; 13. Heart failure (left ventricular ejection fraction less than 30% indicated by the last echocardiogram before surgery); 14. Patients with sick sinus syndrome, severe bradycardia (heart rate less than 50bpm), second-degree or higher atrioventricular block; 15. Patients using mechanical life support before surgery, including intra-aortic balloon counterpulsation (IABP), extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), renal replacement therapy (CRRT); 16. Nursing or pregnant women; 17. Patients with mental or legal disabilities; 18. The patient is participating in another interventional clinical study.

Design outcomes

Primary

MeasureTime frame
incidence of new-onset atrial fibrillation;

Secondary

MeasureTime frame
Postoperative ICU stay time;length of hospital stay;postoperative complications;mortality;

Countries

China

Contacts

Public ContactHu Shengshou

Fuwai Hospital, Chinese Academy of Medical Sciences

huss@fuwaihospital.org+86 13801130863

Outcome results

None listed

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