Atrial Fibrillation Clinical Trial
Official title:
Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery
Verified date | February 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study, the investigators aim to determine whether injecting botulinum toxin into epicardial fat pads is efficacious and safe for decreasing postoperative atrial fibrillation (POAF) after cardiac surgery. The investigators will test the hypothesis that botulinum toxin injected into the epicardial fat pads reduces POAF and length of stay (LOS) without increasing adverse events. This will be a prospective randomized trial of 130 patients undergoing coronary artery bypass graft (CABG), valve surgery or CABG + valve surgery with cardiopulmonary bypass. Patients will be randomized to receive either botulinum toxin (50 units per fat pad, n=65) or normal saline/placebo (1 mL per fat pad, n=65) injected into epicardial fat pads. All patients will receive standardized anesthetic, surgical, and post-surgical care. The primary outcome in this study will be time to occurrence of in-hospital POAF. Based on previous work and a pilot trial showing a pronounced reduction (relative risk reduction 77%) in POAF after injecting botulinum into the epicardial fat pads, the investigators anticipate a significant reduction in the risk for POAF with epicardial botulinum in this cohort, which includes valve surgery patients.
Status | Completed |
Enrollment | 130 |
Est. completion date | December 1, 2018 |
Est. primary completion date | September 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Undergoing cardiac surgery with cardiopulmonary bypass via median sternotomy - coronary artery bypass graft (CABG) - valve surgery - CABG + valve surgery Exclusion Criteria: - < 50years of age - > 90years of age - chronic AF or AF at the time of screening - preoperative heart block (second degree or greater) - LVEF < 25% - renal failure - hepatic failure - known sensitivity to Botulinum toxin - debilitating neuromuscular disease - preoperative need for inotropes/vasopressors or intra-aortic balloon pump - planned MAZE procedure - history of catheter ablation for AF - use of Vaughan-Williams class I or III drugs within 5 elimination half lives (or within 2 months for amiodarone) - undergoing minimally-invasive cardiac surgery - prior cardiac surgery |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Joseph Mathew, M.D. | American Heart Association, Foundation for Anesthesia Education and Research |
United States,
Oh S, Choi EK, Zhang Y, Mazgalev TN. Botulinum toxin injection in epicardial autonomic ganglia temporarily suppresses vagally mediated atrial fibrillation. Circ Arrhythm Electrophysiol. 2011 Aug;4(4):560-5. doi: 10.1161/CIRCEP.111.961854. Epub 2011 Jun 9. — View Citation
Pokushalov E, Kozlov B, Romanov A, Strelnikov A, Bayramova S, Sergeevichev D, Bogachev-Prokophiev A, Zheleznev S, Shipulin V, Salakhutdinov N, Lomivorotov VV, Karaskov A, Po SS, Steinberg JS. Botulinum toxin injection in epicardial fat pads can prevent recurrences of atrial fibrillation after cardiac surgery: results of a randomized pilot study. J Am Coll Cardiol. 2014 Aug 12;64(6):628-9. doi: 10.1016/j.jacc.2014.04.062. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to In-hospital Post-operative Atrial Fibrillation (POAF) | Patients will be seen on a daily basis and the timing of POAF compared between groups. The occurrence of in-hospital POAF will be tracked throughout the hospitalization (up to two weeks) and the time from surgery to the first and subsequent episodes of POAF recorded and compared between groups. POAF will be determined by ECG or telemetry. | From the time of ICU arrival until the time of first documented POAF, or discharge whichever came first, assessed up to 2 weeks | |
Secondary | Number of Participants With In-hospital POAF | Patients will be seen on a daily basis and the occurrence of POAF compared between groups. | The incidence of in-hospital POAF will be tracked throughout the hospitalization (up to two weeks) | |
Secondary | Length of Stay | Total and ICU length of stay will be determined by examining medical records for the length of inpatient hospitalization, assessed over the entire study period (up to two years). ICU and hospital LOS will be recorded and compared between groups | ICU length of stay was measured from time of surgery to time of ICU discharge. Post-operative length of stay was measured from time of surgery to time of hospital discharge. | |
Secondary | Number of Participants With Adverse Events | The total number of postoperative complications (including infectious, neurologic, and renal complications, as well as mortality) and the number of subjects with complications will be monitored and compared between groups. | Adverse events from the time of surgery through hospital discharge, up to 2 weeks |
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