Amiodarone
DrugPatients randomized to the Amiodarone Arm will receive a 5-day course of amiodarone after surgery.
NCT Number: NCT05543278
Postoperative atrial fibrillation is quite common after cardiac surgery with up to 1 in 3 patients experiencing this abnormal heart rhythm. Amiodarone, a medication commonly used to treat atrial fibrillation, has been previously shown to be an effective prophylactic agent at decreasing the occurrence of postoperative atrial fibrillation in patients who underwent coronary artery bypass surgery. However, despite many studies which have demonstrated its effectiveness, it has not been widely used due to the concern of side effects that can occur such as slow heart rate, low blood pressure, and lung toxicity. We have designed a study to test the effectiveness and safety of a short course of postoperative prophylactic amiodarone for patients undergoing non-coronary artery bypass cardiac surgery. We hypothesize that patients who receive the prophylactic amiodarone will have decreased rates of postoperative atrial fibrillation without significantly increased side effects compared to patients who receive the standard postoperative care after non-coronary artery bypass cardiac surgery.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients randomized to the Amiodarone Arm will receive a 5-day course of amiodarone after surgery.
Time frame: At least 1 minute duration, occurring before or on postoperative day 7
The occurrence of postoperative atrial fibrillation detected by continuous telemetry, 12-lead electrocardiogram, and/or continuous ambulatory monitoring device through postoperative day 7.
Time frame: Either in-hospital or within 30 days of procedure
Operative mortality as defined by either in-hospital death or death within 30 days of discharge.
Time frame: Either in-hospital or within 30 days of procedure
characterized by deficits lasting > 24 hours and/or imaging findings of infarction
Time frame: Either in-hospital or within 30 days of procedure
characterized by examination findings lasting < 24 hours without associated imaging findings
Time frame: Either in-hospital or within 30 days of procedure
Whether the patient required electrical cardioversion for hemodynamically unstable atrial fibrillation
Time frame: Either in-hospital or within 30 days of procedure
New hemodynamic instability (mean arterial pressure < 65 mmHg) after surgery
Time frame: Either in-hospital or within 30 days of procedure
New indication of systemic anticoagulation for stroke prophylaxis due to atrial fibrillation
Time frame: Either in-hospital or within 30 days of procedure
Myocardial infarction diagnosed based on ECG and laboratory testing including pursued intervention and/or findings from subsequent angiography will be compared between intervention groups. To be considered a myocardial infarction, the diagnosis will have to be confirmed and documented in the chart by a board-certified cardiologist.
Time frame: Up to 90 days
Atrial fibrillation as diagnosed by final ECG
Time frame: Up to 90 days
The postoperative length of stay will be calculated starting from the end of the procedure to time of discharge.
Time frame: Within 30 days of procedure
Rates of hospital readmission will be estimated for patients in each of the study intervention groups. Readmissions will be counted in this calculation if patients are admitted to the hospital. Emergency room visits without admission and outpatient visits will not count toward this calculation of readmission rates.
Time frame: Either in-hospital or within 30 days of procedure
Symptomatic bradycardia (HR < 55 bpm) requiring intervention
Time frame: Either in-hospital or within 30 days of procedure
Clinical diagnosis of amiodarone-related pulmonary toxicity that uses a combination of x-ray findings consistent with known amiodarone-related pulmonary toxicity and clinical findings including shortness of breath, non-productive cough, and other diagnoses have been excluded.
Contact information is provided by the study sponsor or research team.
Massachusetts General Hospital
Other
Acronym: PATRONUS
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