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A multicenter randomized controlled study on amiodarone intervention for high-risk patients with atrial fibrillation during the perioperative period of coronary artery bypass grafting

A multicenter randomized controlled study on amiodarone intervention for high-risk patients with atrial fibrillation during the perioperative period of coronary artery bypass grafting

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124273
Enrollment
Unknown
Registered
2026-05-09
Start date
2025-12-17
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Coronary atherosclerotic heart disease

Interventions

Intervention group:The intervention group was given amiodarone hydrochloride injection. Immediately after entering the ICU, the infusion was continued at a rate of 1 mg/min for 12 hours, and then chan
Control group:The control group was given a 5% glucose solution. The start time, duration, and administration rate of the treatment were the same as those for the intervention group.

Sponsors

FUWAI Hospital, CAMS&PUMC
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. Patients undergoing CABG elective surgery for the first time; 3. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previous history of cardiac surgery 2. CABG emergency surgery; 3. Simultaneously undergoing CABG and other cardiac and vascular surgeries; 4. Hemodynamic instability,Need medication or mechanical support; 5. Atrial tachycardia,heart failure,History of atrial flutter or other severe arrhythmia; 6. Using implantable electronic devices in the heart; 7. Previous history of continuous use of AMIO for more than 14 days; 8. There are contraindications for AMIO; (1)Patients with sinus bradycardia and sinoatrial conduction block without artificial pacemaker implantation; (2)Patients with sinoatrial node disease without artificial pacemaker implantation;(Risk of sinus arrest); (3)Patients with high atrioventricular conduction disorders who have not been implanted with artificial pacemakers; (4)Double or triple branch conduction block,Unless a permanent artificial pacemaker is installed; (5)Thyroid dysfunction;(6)Known allergy to iodine AMIO or its auxiliary materials; (7)Pregnancy or lactation period; (8)Circulation failure or severe hypotension; (9)Intravenous infusion should not be used for hypotension, severe respiratory failure, cardiomyopathy, or HF (which may worsen the condition); (10)Used in combination with certain drugs that can cause tip twisting and ventricular tachycardia(Excluding antiparasitic drugs, antipsychotic drugs, and methadone):a. Class Ia antiarrhythmic drugs (Quinidine, Dihydroquinidine, Disopyramide), b. Class III antiarrhythmic drugs(sotalol, Dofetilide, Ibutilide) c. Other drugs:Arsenic compound, Bepridil, Cisapride, Citalopram, Escitalopram, Diphemanil, Dolasetron Injection, Domperidone, Dronedarone, Dronedarone, Erythromycin Injection, Levofloxaxin, Mequitazine, Mizolastine, Moxifloxacin, Prucalopride, Spiramycin, Vincamine, Sultopride, Telaprevir, Cobicistat, Pentamidine; (11)These contraindications do not apply to the emergency treatment of ventricular fibrillation related cardiac arrest with ineffective external defibrillation using amiodarone for cardiopulmonary resuscitation,The above refers to the instruction manual of Sanofi Hydrochloride Amiodarone Injection(Sanofi Winthrop Industrie, France); 9. Cancer; 10. Simultaneously participate in other drug or device intervention trials; 11. Poor compliance or Unable to complete the follow-up visit; 12. Refusal to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Postoperative atrial fibrillation;

Secondary

MeasureTime frame
Main adverse cardiovascular and cerebrovascular events;Acute kidney injury;Delirium;Infection;

Countries

China

Contacts

Public ContactDu Juan

FUWAI Hospital, CAMS&PUMC

dujuan_fuwai@163.com+86 186 0121 5135

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026