Atrial Fibrillation
Conditions
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.
Interventions
DRUGAMIODARONE
Assess the effectiveness of different dosing strategies of amiodarone.
Sponsors
Kevin W Hatton, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normal Sinus Rhythm -24 HRS | 24-hours after receiving amiodarone bolus | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Target Heart Rate Time | 24-hours after receiving amiodarone bolus | 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 | 24-hours after receiving amiodarone bolus | 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 | duration of ICU and hospital visit, up to 20 days | 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 | duration of ICU and hospital visit, up to 20 days | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional Amiodarone Dosing Regimen (CDR) 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.
AMIODARONE: Assess the effectiveness of different dosing strategies of amiodarone. | 2 |
| Repeated Amiodarone Bolus Dosing Regimen (RBDR) 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.
AMIODARONE: Assess the effectiveness of different dosing strategies of amiodarone. | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | Conventional Amiodarone Dosing Regimen (CDR) | Repeated Amiodarone Bolus Dosing Regimen (RBDR) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 2 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
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.
Time frame: 24-hours after receiving amiodarone bolus
Population: No data released because enrollment was three participants, and one group had a singular participant. Therefore, confidentiality of the participant's health information could be impacted if the outcome measures were displayed.for that group with only one participant. Additionally, the other group only had two participants, again, release of this information could impact their right to confidentiality.
Secondary
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
Time frame: duration of ICU and hospital visit, up to 20 days
Population: No data released because enrollment was three participants, and one group had a singular participant. Therefore, confidentiality of the participant's health information could be impacted if the outcome measures were displayed.for that group with only one participant. Additionally, the other group only had two participants, again, release of this information could impact their right to confidentiality.
Secondary
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
Time frame: duration of ICU and hospital visit, up to 20 days
Population: No data released because enrollment was three participants, and one group had a singular participant. Therefore, confidentiality of the participant's health information could be impacted if the outcome measures were displayed.for that group with only one participant. Additionally, the other group only had two participants, again, release of this information could impact their right to confidentiality.
Secondary
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
Time frame: 24-hours after receiving amiodarone bolus
Population: No data released because enrollment was three participants, and one group had a singular participant. Therefore, confidentiality of the participant's health information could be impacted if the outcome measures were displayed.for that group with only one participant. Additionally, the other group only had two participants, again, release of this information could impact their right to confidentiality.
Secondary
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 frame: 24-hours after receiving amiodarone bolus
Population: No data released because enrollment was three participants, and one group had a singular participant. Therefore, confidentiality of the participant's health information could be impacted if the outcome measures were displayed.for that group with only one participant. Additionally, the other group only had two participants, again, release of this information could impact their right to confidentiality.