Pragmatic Amiodarone Trial to Reduce Postoperative Atrial Fibrillation in Patients Undergoing Cardiac Surgery

Обзор

Postoperative atrial fibrillation is quite common after cardiac surgery with up to 1 in 3 patients experiencing this abnormal heart rhythm. Amiodarone, a medication commonly used to treat atrial fibrillation, has been previously shown to be an effective prophylactic agent at decreasing the occurrence of postoperative atrial fibrillation in patients who underwent coronary artery bypass surgery. However, despite many studies which have demonstrated its effectiveness, it has not been widely used due to the concern of side effects that can occur such as slow heart rate, low blood pressure, and lung toxicity. We have designed a study to test the effectiveness and safety of a short course of postoperative prophylactic amiodarone for patients undergoing non-coronary artery bypass cardiac surgery. We hypothesize that patients who receive the prophylactic amiodarone will have decreased rates of postoperative atrial fibrillation without significantly increased side effects compared to patients who receive the standard postoperative care after non-coronary artery bypass cardiac surgery.

Вмешательства

• Препарат Amiodarone
  Patients randomized to the Amiodarone Arm will receive a 5-day course of amiodarone after surgery.

Первичные конечные точки

• Postoperative atrial fibrillation [Срок оценки: At least 1 minute duration, occurring before or on postoperative day 7]

Вторичные конечные точки (12)

• Operative mortality [Срок оценки: Either in-hospital or within 30 days of procedure]
• Stroke [Срок оценки: Either in-hospital or within 30 days of procedure]
• Transient ischemic attack [Срок оценки: Either in-hospital or within 30 days of procedure]
• Electrical cardioversion [Срок оценки: Either in-hospital or within 30 days of procedure]
• Hemodynamic instability [Срок оценки: Either in-hospital or within 30 days of procedure]
• Initiation of systemic anticoagulation [Срок оценки: Either in-hospital or within 30 days of procedure]
• Myocardial infarction [Срок оценки: Either in-hospital or within 30 days of procedure]
• Persistence of atrial fibrillation at discharge [Срок оценки: Up to 90 days]
• Postoperative hospital length of stay [Срок оценки: Up to 90 days]
• Readmission [Срок оценки: Within 30 days of procedure]
• Symptomatic bradycardia [Срок оценки: Either in-hospital or within 30 days of procedure]
• Number of patients with Amiodarone-related pulmonary toxicity [Срок оценки: Either in-hospital or within 30 days of procedure]

Критерии участия

Критерии включения

• >= 18 years of age
• All genders
• All non-coronary artery bypass cardiac surgery patients
• Preoperative normal sinus rhythm

Критерии исключения

• Pre-existing atrial fibrillation or atrial arrhythmias
• Pre-existing heart block
• Cardiogenic shock
• Sick sinus syndrome
• Marked sinus bradycardia
• Preoperative amiodarone use
• Contraindication to amiodarone use

• PR interval > 240 ms
• QTc > 550 ms
• 2nd or 3rd degree heart block
• Liver impairment (INR > 1.7, AST/ALT > 2x normal)
• Uncontrolled hyperthyroidism or hypothyroidism
• Interstitial lung disease
• Pregnancy and/or breastfeeding
• Known hypersensitivity to any components of amiodarone, including iodine
• Emergent operation
• Planned MAZE or Pulmonary Vein Isolation procedure

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039. PMID 28369234
• Arsenault KA, Yusuf AM, Crystal E, Healey JS, Morillo CA, Nair GM, Whitlock RP. Interventions for preventing post-operative atrial fibrillation in patients undergoing heart surgery. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003611. doi: 10.1002/14651858.CD003611.pub3. PMID 23440790
• Chatterjee S, Sardar P, Mukherjee D, Lichstein E, Aikat S. Timing and route of amiodarone for prevention of postoperative atrial fibrillation after cardiac surgery: a network regression meta-analysis. Pacing Clin Electrophysiol. 2013 Aug;36(8):1017-23. doi: 10.1111/pace.12140. Epub 2013 Apr 29. PMID 23627761
• Buckley MS, Nolan PE Jr, Slack MK, Tisdale JE, Hilleman DE, Copeland JG. Amiodarone prophylaxis for atrial fibrillation after cardiac surgery: meta-analysis of dose response and timing of initiation. Pharmacotherapy. 2007 Mar;27(3):360-8. doi: 10.1592/phco.27.3.360. PMID 17316148
• Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/Amer PMID 34882435
• Colunga Biancatelli RM, Congedo V, Calvosa L, Ciacciarelli M, Polidoro A, Iuliano L. Adverse reactions of Amiodarone. J Geriatr Cardiol. 2019 Jul;16(7):552-566. doi: 10.11909/j.issn.1671-5411.2019.07.004. PMID 31447894
• Orr CF, Ahlskog JE. Frequency, characteristics, and risk factors for amiodarone neurotoxicity. Arch Neurol. 2009 Jul;66(7):865-9. doi: 10.1001/archneurol.2009.96. PMID 19597088
• Wolkove N, Baltzan M. Amiodarone pulmonary toxicity. Can Respir J. 2009 Mar-Apr;16(2):43-8. doi: 10.1155/2009/282540. PMID 19399307

Идентификаторы

NCT: NCT05543278 · 2022P001732

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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