Trial Outcomes & Findings for Repeated Amiodarone Dosing In Cardiac surgicaL Procedures (NCT NCT05004077)
NCT ID: NCT05004077
Last Updated: 2023-11-18
Results Overview
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.
TERMINATED
PHASE4
3 participants
24-hours after receiving amiodarone bolus
2023-11-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repeated Amiodarone Dosing In Cardiac surgicaL Procedures
Baseline characteristics by cohort
| Measure |
Conventional Amiodarone Dosing Regimen (CDR)
n=2 Participants
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.
|
Repeated Amiodarone Bolus Dosing Regimen (RBDR)
n=1 Participants
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.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24-hours after receiving amiodarone bolusPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24-hours after receiving amiodarone bolusPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24-hours after receiving amiodarone bolusPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: duration of ICU and hospital visit, up to 20 daysPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: duration of ICU and hospital visit, up to 20 daysPopulation: 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.
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
Outcome measures
Outcome data not reported
Adverse Events
Conventional Amiodarone Dosing Regimen (CDR)
Repeated Amiodarone Bolus Dosing Regimen (RBDR)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place