Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will be comparing the combination of amiodarone and NAC (n=122) to amiodarone alone and NAC matched placebo (n=122) to determine the rates with which sustained (lasting >30 seconds) or clinically significant POAF is reduced in high risk patients within 7 days after major thoracic surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: The Cleveland Clinic; Vanderbilt University School of Medicine; Washington University School of Medicine
• Treatments: Acetylcysteine; Amiodarone; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Patients ≥18 years old scheduled for elective thoracic surgery (segmentectomy, lobectomy or bi-lobectomy, pneumonectomy or esophagectomy) and meeting one of the four following risk criteria:

• 1. Female & BNP ≥ 25pg/ml (no age limit)

• 2. Male gender <75 & BNP ≥ 25pg/ml

• 3. Male- age ≥75 (No BNP limit)

• 4. History of prior AF

• Patients in sinus rhythm.

• Patients with stable respiratory status (no respiratory distress).

• Patients capable of providing written, informed consent.

Exclusion Criteria:

• Patients scheduled for extrapleural pneumonectomy.

• Hemodynamically unstable patients (not in cardiogenic shock or having an acute MI).

• Patients with 2nd or 3rd degree atrioventricular (AV) block.

• Patients with hypersensitivity to amiodarone or NAC.

• Patients already taking class Ic or III antiarrhythmic drugs.

• Hepatic insufficiency (≤2 times the upper normal limit of transaminase levels).

• Renal insufficiency (creatinine ≥2.0 mg/dl).

• Known pregnancy.