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

Memorial Sloan Kettering Cancer Center (MSK) logo

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

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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