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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Controlled Trial of Combined Amiodarone and N-Acetylcysteine Versus Amiodarone Plus Placebo for the Prevention of Atrial Fibrillation in High Risk Patients Undergoing Thoracic Surgery

Conditions
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Thoracic Surgery, Atrial Fibrillation in High Risk Patients

Intervention / Treatment
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* Drug: Amiodarone
* Drug: N-Acetylcysteine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Amiodarone + Placebo<br>Amiodarone loading: 150 mg IV in PACU over one hour, then 1.0 gm/24h x 2 + NAC loading matching placebo; 50 mg/kg IV in PACU over one hour, then 50 mg/kg/24h x 2 NAC matched placebo continuously for 48 hours. | Drug: Amiodarone<br> <br> Drug: Placebo<br> <br> |
| Experimental: Amiodarone + N-Acetylcysteine<br>Amiodarone loading: 150 mg IV in PACU over one hour, then 1.0 gm/24h x 2 + NAC loading: 50 mg/kg IV in PACU over one hour, then 50 mg/kg/24h x 2 and then continuously for 48 hours. | Drug: Amiodarone<br> <br> Drug: N-Acetylcysteine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF) | Atrial arrhythmias will be considered and defined as atrial fibrillation/flutter (AF) lasting great than 30 seconds and/or sustained supraventricular tachycardia (SVT) that are detected by continuous telemetry or that are clinically significant, requiring intervention and documented by 12-lead ECG by the clinical staff. | within 7 days since operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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16-307, Amiodarone, N-Acetylcysteine