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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| The Cleveland Clinic | OTHER |
| Vanderbilt University School of Medicine | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amiodarone + Placebo | Placebo Comparator | 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. |
|
| Amiodarone + N-Acetylcysteine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amiodarone | Drug |
| ||
| N-Acetylcysteine |
| 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 |
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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:
Patients in sinus rhythm.
Patients with stable respiratory status (no respiratory distress).
Patients capable of providing written, informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Amar, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington School of Medicine in St. Louis | St Louis | Missouri | 63110 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| Drug |
|
| Placebo | Drug |
|
| Memorial Sloan Kettering Basking Ridge (Consent only) |
| Basking Ridge |
| New Jersey |
| United States |
| Memorial Sloan Kettering Monmouth (Consent only) | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Bergen (Consent only) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (Consent only) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Consent only) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Rockville Centre (Consent only) | Rockville Centre | New York | 11570 | United States |
| Memorial Sloan Kettering Nassau (Consent only) | Uniondale | New York | 11553 | United States |
| ID | Term |
|---|---|
| D000638 | Amiodarone |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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