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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 3

Conditions: Atrial Fibrillation in High Risk Patients; Thoracic Surgery

Treatments: Drug: N-Acetylcysteine; Drug: Placebo; Drug: Amiodarone

Study type: Interventional

Funder types: Other

Identifiers

NCT02750319

16-307

Details and patient eligibility

About

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.

Enrollment: 184 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 2 patient groups, including a placebo group

Amiodarone + Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Amiodarone

Drug: Placebo

Amiodarone + N-Acetylcysteine

Experimental group

Description:

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.

Treatment:

Drug: Amiodarone

Drug: N-Acetylcysteine