Back to resultsRepeated Amiodarone Dosing In Cardiac surgicaL Procedures (RADICAL)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AMIODARONE
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Subject must be 18 years old or older
- Subject must be willing to give written informed consent
- Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or septal defect repair, thoracic aortic replacement surgery, or any combination of these procedures
Exclusion Criteria:
- Documented allergy to amiodarone or iodine
- History of atrial fibrillation or other heart conduction system abnormality
- History of cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
- Scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
- Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support
- History of pre-existing respiratory system disease requiring oxygen therapy prior to admission
- History of cirrhosis or other chronic liver diseases
- Pregnancy or breastfeeding mothers
- Prisoner status
Sites / Locations
- University of Kentucky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional amiodarone dosing regimen (CDR)
Repeated amiodarone bolus dosing regimen (RBDR)
Arm Description
Initial amiodarone bolus of 150 mg IV over 10 minutes then a 24-hour amiodarone loading infusion (1 mg/min for 6 hours followed by 0.5 mg/min for 18 hours), followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.
Initial amiodarone bolus of 150 mg IV over 10 minutes, then 1.0 mg/min IV amiodarone infusion for 6 hours, then a 0.5 mg/min IV amiodarone infusion for 18 hours, followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. In addition, patients in the RBDR will receive an additional 150 mg IV amiodarone bolus whenever the patient develops tachycardia (Heart Rate (HR) = 110 beats per minute) lasting more than 10 minutes. This bolus may be repeated up to a total of 5 times (6 total boluses) over the first 24 hours. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.
Outcomes
Primary Outcome Measures
Normal Sinus Rhythm -24 HRS
Percentage of patients who develop stable POAF after non-emergent cardiac surgery, the percentage of patients who have converted to NSR at 24-hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have converted to NSR after a conventional amiodarone IV loading dose regimen.
Secondary Outcome Measures
Total Target Heart Rate Time
Total time, in minutes, during the first 24 hours that the patient achieves target HR (HR < 110 bpm) between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Time to Target Heart Rate
Time to achieve target HR (HR < 110 bpm) between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Normal Sinus Rhythm -Hospital Index
Percentage of patients who achieve NSR by ICU discharge and hospital discharge between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Recurrent AF
Percentage of patients who have recurrent AF before ICU discharge and before hospital discharge and patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05004077
Brief Title
Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
Acronym
RADICAL
Official Title
Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
limited enrollment
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kevin Hatton
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a single-center, prospective, randomized, open-label trial of subjects who develop atrial fibrillation after non-emergent cardiac surgery at the University of Kentucky Chandler Medical Center (UKCMC). Patients will be randomized to receive either a conventional amiodarone dosing regimen (CDR) or a repeated amiodarone bolus dosing regimen (RBDR).
Detailed Description
This study will screen and consent approximately 150 patients undergoing non-emergent cardiac surgery. Approximately 60 of these patients are likely to develop stable postoperative atrial fibrillation (POAF) in the postoperative period. Amiodarone is commonly given as an initial intravenous (IV) bolus (150 mg IV) followed by a combined IV and oral load to a total dose of 8 gm. Because of amiodarone's beta-blocker activity, the IV bolus in patients with POAF is associated with a reduced heart rate that may lead to restoration of NSR. For this reason, some clinicians will provide up to 5 additional IV amiodarone boluses during the drug's loading period to treat RVR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional amiodarone dosing regimen (CDR)
Arm Type
Active Comparator
Arm Description
Initial amiodarone bolus of 150 mg IV over 10 minutes then a 24-hour amiodarone loading infusion (1 mg/min for 6 hours followed by 0.5 mg/min for 18 hours), followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.
Arm Title
Repeated amiodarone bolus dosing regimen (RBDR)
Arm Type
Active Comparator
Arm Description
Initial amiodarone bolus of 150 mg IV over 10 minutes, then 1.0 mg/min IV amiodarone infusion for 6 hours, then a 0.5 mg/min IV amiodarone infusion for 18 hours, followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. In addition, patients in the RBDR will receive an additional 150 mg IV amiodarone bolus whenever the patient develops tachycardia (Heart Rate (HR) = 110 beats per minute) lasting more than 10 minutes. This bolus may be repeated up to a total of 5 times (6 total boluses) over the first 24 hours. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.
Intervention Type
Drug
Intervention Name(s)
AMIODARONE
Intervention Description
Assess the effectiveness of different dosing strategies of amiodarone.
Primary Outcome Measure Information:
Title
Normal Sinus Rhythm -24 HRS
Description
Percentage of patients who develop stable POAF after non-emergent cardiac surgery, the percentage of patients who have converted to NSR at 24-hours after receiving a repeated amiodarone bolus and loading dose regimen to the percentage of patients who have converted to NSR after a conventional amiodarone IV loading dose regimen.
Time Frame
24-hours after receiving amiodarone bolus
Secondary Outcome Measure Information:
Title
Total Target Heart Rate Time
Description
Total time, in minutes, during the first 24 hours that the patient achieves target HR (HR < 110 bpm) between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Time Frame
24-hours after receiving amiodarone bolus
Title
Time to Target Heart Rate
Description
Time to achieve target HR (HR < 110 bpm) between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Time Frame
24-hours after receiving amiodarone bolus
Title
Normal Sinus Rhythm -Hospital Index
Description
Percentage of patients who achieve NSR by ICU discharge and hospital discharge between patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Time Frame
duration of ICU and hospital visit, up to 20 days
Title
Recurrent AF
Description
Percentage of patients who have recurrent AF before ICU discharge and before hospital discharge and patients who receive a repeated amiodarone bolus dosing regimen and those who receive a conventional amiodarone bolus dosing regimen
Time Frame
duration of ICU and hospital visit, up to 20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject must be 18 years old or older
Subject must be willing to give written informed consent
Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or septal defect repair, thoracic aortic replacement surgery, or any combination of these procedures
Exclusion Criteria:
Documented allergy to amiodarone or iodine
History of atrial fibrillation or other heart conduction system abnormality
History of cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
Scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support
History of pre-existing respiratory system disease requiring oxygen therapy prior to admission
History of cirrhosis or other chronic liver diseases
Pregnancy or breastfeeding mothers
Prisoner status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Hatton, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
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