Recruiting

Prophylaxis

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04392921

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amiodarone

Placebo

Study Details

Brief summary:

After surgery on the lungs or esophagus, 12-46% of patients experience an irregular heart rhythm called atrial fibrillation. Although usually transient, post-operative atrial fibrillation is associated with longer stay in hospital, greater complications, and increased risk of death. Several medications have been shown to be effective at reducing the risk of atrial fibrillation after their surgery with the greatest effectiveness and safety demonstrated with amiodarone. Nevertheless, amiodarone has potential side effects, and so it is only recommended in patients with increased risk of developing atrial fibrillation. A tool has been developed and validated to identify high-risk patients but no clinical trial has looked at the effectiveness of administering amiodarone in this high-risk group. This study aims to assess the feasibility and safety of conducting a clinical trial where patients are randomized to receive amiodarone or placebo. This is critical before considering a full-scale trial to assess the effectiveness of amiodarone in reducing atrial fibrillation after surgery on the lungs or esophagus.

Conditions

Atrial Fibrillation

Study ID

NCT04392921

Start date

Mar 7, 2022

Status verified date

Mar, 2023

Completion date

Apr, 2024

Anticipated

Primary completion date

Mar, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 18 years or greater
  • Undergoing major non-cardiac pulmonary or esophageal surgery (including esophagectomy, pulmonary wedge resection, lobar resection, pneumonectomy, or gastrectomy)
  • POAF prediction score greater than or equal to 4

Exclusion Criteria:

  • Aged less than 18 years
  • History of atrial arrhythmia (paroxysmal or persistent), or Wolf-Parkinson-White syndrome (WPW), or 2nd or 3rd degree heart block without a pacemaker
  • Current antiarrythmic therapy (including amiodarone, propafenone, sotalol, flecainide, and dronedarone)
  • Previous severe adverse reaction or contraindication to amiodarone (including pre-existing interstitial lung disease, or history of hepatotoxicity from amiodarone)
  • QTc interval longer than 450ms
  • Serum alanine transaminase or aspartate transaminase over 3 times the upper limit of normal, or Child-Pugh class C
  • Allergy to amiodarone

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Patients randomized to amiodarone treatment

placebo comparator: Control Arm

Patients randomized to placebo treatment

Interventions

Amiodarone

Patients will undergo one of the two regimens of amiodarone, based on their ability to tolerate po (per os) intake in the post-operative period:

• All patient will receive 1050mg of amiodarone in 100mL of 5% dextrose administered intravenously initiated at the time of anesthesia induction at a rate of 0.73mg/min or 43.75mg/h and continued over 24 hours followed by:

  • If able to tolerate po intake: 400mg po BID for post-operative days 1 to 5 or until the day of discharge (whichever occurs first).
  • If unable to tolerate po intake: daily infusion of 1050mg in 100mL of 5% dextrose for postoperative days 1 to 5 or until the day of discharge (whichever occurs first).

Placebo

Patients will undergo one of the two schedules or intravenous infusion, based on their ability to tolerate po intake in the post-operative period:

  • All patients will receive 100mL of 5% dextrose administered intravenously initiated at the time of anesthesia induction at a rate of 0.73mg/min or 43.75mg/h and continued over 24 hours followed by:

o If able to tolerate po intake: 400mg po BID for post-operative days 1 to 5 or until the day of discharge (whichever occurs first).
  • Esophagectomy patient will receive 100mL of 5% dextrose at the time of anesthesia induction at a rate of what would be 0.73mg/min or 43.75mg/h if it contained 1050mg of amiodarone, followed by daily infusion of 100mL of 5% dextrose for 4 days or until the day of discharge (whichever occurs first).

Primary outcome measure

  • Capability for enrolment [ Time Frame: Upon study completion, 1 year following study initiation ]
  • Proportion of patients randomized who receive the intervention [ Time Frame: Upon study completion, 1 year following study initiation ]
  • Knowledge of which patients received intervention and placebo [ Time Frame: Upon study completion, 1 year following study initiation ]
  • Intervention delivery [ Time Frame: Upon study completion, 1 year following study initiation ]
  • Protocol compliance [ Time Frame: Upon study completion, 1 year following study initiation ]
  • Adherence to safety protocol [ Time Frame: Upon study completion, 1 year following study initiation ]
  • Proportion of patients for which data could be abstracted [ Time Frame: Upon study completion, 1 year following study initiation ]
  • Resources [ Time Frame: Upon study completion, 1 year following study initiation ]

Central Contacts and Locations

Central contacts

Andrew JE Seely, MD, PhD

613-737-8899aseely@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Andrew JE Seely, MD, PhD, FRCSC

613-737-8899aseely@ohri.ca

Principal Investigator:

Andrew JE Seely, MD, PhD, FRCSC

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Mar 29, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2023-03-29.