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

Primary Purpose

Thoracic Surgery, Atrial Fibrillation in High Risk Patients

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Amiodarone
N-Acetylcysteine
Placebo
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Surgery focused on measuring Amiodarone, N-Acetylcysteine, 16-307

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Washington School of Medicine in St. Louis
  • Memorial Sloan Kettering Basking Ridge (Consent only)
  • Memorial Sloan Kettering Monmouth (Consent only)
  • Memorial Sloan Kettering Bergen (Consent only)
  • Memorial Sloan Kettering Commack (Consent only)
  • Memorial Sloan Kettering Westchester (Consent only)
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Rockville Centre (Consent only)
  • Memorial Sloan Kettering Nassau (Consent only)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Amiodarone + Placebo

Amiodarone + N-Acetylcysteine

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2016
Last Updated
May 15, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Washington University School of Medicine, The Cleveland Clinic, Vanderbilt University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02750319
Brief Title
Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Washington University School of Medicine, The Cleveland Clinic, Vanderbilt University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Surgery, Atrial Fibrillation in High Risk Patients
Keywords
Amiodarone, N-Acetylcysteine, 16-307

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amiodarone + Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Amiodarone + N-Acetylcysteine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Intervention Type
Drug
Intervention Name(s)
N-Acetylcysteine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
rate of sustained (lasting >30 seconds) or clinically significant post-operative atrial fibrillation (POAF)
Description
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.
Time Frame
within 7 days since operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Amar, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent only)
City
Basking Ridge
State/Province
New Jersey
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth (Consent only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen (Consent only)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack (Consent only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Westchester (Consent only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Rockville Centre (Consent only)
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Memorial Sloan Kettering Nassau (Consent only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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