Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT05780320
Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery with an estimated incidence around 35%. It has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among others. Previous studies including meta-analyses demonstrate a protective benefit of prophylactic amiodarone to decrease the risk of POAF. However, this has not been widely adopted, and recent society guidelines only give prophylactic amiodarone a Class IIA recommendation, citing risk of amiodarone-related toxicity and hypotension as reasons for the Class IIA recommendation. A meta-analysis comparing cumulative doses of amiodarone found that moderate to higher doses of amiodarone have a marginally increased benefit in reducing the incidence of postoperative atrial fibrillation over lower doses; however, the study did not assess risk of complications stratified by cumulative doses, which has been previously described. Finally, a recent meta-analysis showed that a posterior pericardiotomy was highly effective at reducing postoperative atrial fibrillation. Consequently, the investigators' institution has adopted a pharmaco-surgical approach (prophylactic amiodarone and posterior pericardiotomy) in an effort to reduce postoperative atrial fibrillation after coronary artery bypass cardiac surgery for all patients who meet inclusion/exclusion criteria.
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Notify Me18 year and older
All sexes
Observational
Boston, Massachusetts, 02114, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Procedures:
Patients after the implementation of the protocol receive postoperative prophylactic amiodarone and a posterior pericardiotomy.
The amiodarone regimen consists of amiodarone 1mg/min x 10 hours (600 mg total) via central line upon arrival to the intensive care unit followed by 400 mg PO BID on postoperative days 1 and 2 followed by 200 mg PO BID on postoperative days 3 and 4 or until discharge, whichever occurs first.
The posterior pericardiotomy occurs during the cardiac procedure.
Time frame: Prior to patient discharge or within 30 days after surgery.
At least 1 minute duration detected by continuous telemetry or 12-lead electrocardiogram.
Time frame: Either in-hospital death or death within 30 days of discharge
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
New indication of systemic anticoagulation for stroke prophylaxis due to atrial fibrillation
Time frame: At postoperative surgical visit (around 4-6 weeks)
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.
Time frame: Either in-hospital or within 30 days of procedure
Postoperative pleural effusions requiring interventions including thoracostomy drainage or surgical drainage
Massachusetts General Hospital
Other
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