Trial Outcomes & Findings for Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery (NCT NCT00127712)

NCT ID: NCT00127712

Last Updated: 2013-09-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 130 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2013-09-18

Participant Flow

Participant milestones

Measure	Amiodarone Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery	Control Control group
Overall Study STARTED	65	65
Overall Study COMPLETED	60	65
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Measure	Amiodarone Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery	Control Control group
Overall Study Adverse Event	3	0
Overall Study Lack of GI access to continue	2	0

Baseline Characteristics

Prevention of Atrial Fibrillation Following Noncardiac Thoracic Surgery

Baseline characteristics by cohort

Measure	Amiodarone n=65 Participants Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery	Control n=65 Participants Control group	Total n=130 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	39 Participants n=7 Participants	83 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Age Continuous	61 years STANDARD_DEVIATION 8 • n=5 Participants	63 years STANDARD_DEVIATION 9 • n=7 Participants	62 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Region of Enrollment United States	65 participants n=5 Participants	65 participants n=7 Participants	130 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Measure	Amiodarone n=65 Participants Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery	Control n=65 Participants Control group
Incidence of Atrial Fibrillation Requiring Treatment	9 participants	21 participants

PRIMARY outcome

Timeframe: 7 days

Outcome measures

Measure	Amiodarone n=65 Participants Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery	Control n=65 Participants Control group
Incidence of Atrial Fibrillation Lasting Longer Than 30 Seconds	9 Participants	22 Participants

SECONDARY outcome

Timeframe: Duration of hospitalization

Outcome measures

Measure	Amiodarone n=65 Participants Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery	Control n=65 Participants Control group
Length of Intensive Care Unit Stay	46 Hours Interval 0.0 to 1416.0	84 Hours Interval 0.0 to 984.0

SECONDARY outcome

Timeframe: Duration of hospitalization

Outcome measures

Measure	Amiodarone n=65 Participants Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery	Control n=65 Participants Control group
Length of Hospital Stay	7 Days Interval 3.0 to 59.0	8 Days Interval 3.0 to 41.0

Adverse Events

Amiodarone

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Amiodarone n=65 participants at risk Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery	Control n=65 participants at risk Control group
General disorders death	3.1% 2/65 • Number of events 2	1.5% 1/65 • Number of events 1

Other adverse events

Measure	Amiodarone n=65 participants at risk Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery	Control n=65 participants at risk Control group
General disorders Hypotension	32.3% 21/65 • Number of events 21	33.8% 22/65 • Number of events 22

Additional Information

James E. Tisdale

Purdue University

Phone: 317-613-2315

Email: jtisdale@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place