Trial Outcomes & Findings for Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit (NCT NCT01461733)
NCT ID: NCT01461733
Last Updated: 2014-09-15
Results Overview
Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
25 participants
Primary outcome timeframe
From randomization to conversion or ICU discharge up to 100 months.
Results posted on
2014-09-15
Participant Flow
Participant milestones
| Measure |
Amiodarone
standard dose amiodarone
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit
Baseline characteristics by cohort
| Measure |
Amiodarone
n=12 Participants
standard dose amiodarone
amiodarone: standard dose amiodarone
|
Placebo
n=12 Participants
Placebo: placebo delivered blinded
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 17 • n=5 Participants
|
61 years
STANDARD_DEVIATION 17 • n=7 Participants
|
65 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to conversion or ICU discharge up to 100 months.Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.
Outcome measures
| Measure |
Amiodarone
n=8 Participants
standard dose amiodarone
amiodarone: standard dose amiodarone
|
Placebo
n=8 Participants
Placebo: placebo delivered blinded
|
|---|---|---|
|
Conversion From Atrial Fibrillation to Sinus Rhythm
|
8 participants
|
5 participants
|
Adverse Events
Amiodarone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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