Trial Outcomes & Findings for Study of Amiodarone Given Before Lung Surgery to Prevent Atrial Fibrillation After Lung Resection (NCT NCT00300495)

NCT ID: NCT00300495

Last Updated: 2017-04-28

Results Overview

Number of patients with post-operative atrial fibrillation

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 19 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2017-04-28

Participant Flow

One patient in the control group was excluded because, after patient was enrolled, patient had mediastinoscopy that showed more advanced disease. Thus, patient did not undergo lung resection. Therefore this patient was excluded from the study.

Participant milestones

Measure	1 - Amiodarone Perioperative amiodarone Amiodarone: Perioperative orally administered Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery	2 - Control Control arm, standard care with no perioperative amiodarone Control arm, standard care: Control
Overall Study STARTED	10	9
Overall Study COMPLETED	6	8
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	1 - Amiodarone Perioperative amiodarone Amiodarone: Perioperative orally administered Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery	2 - Control Control arm, standard care with no perioperative amiodarone Control arm, standard care: Control
Overall Study Protocol Violation	4	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	1 - Amiodarone n=10 Participants Perioperative amiodarone Amiodarone: Perioperative orally administered	2 - Control n=9 Participants Control arm, standard care with no perioperative amiodarone Control arm, standard care: Control	Total n=19 Participants Total of all reporting groups
Age, Customized Age > 18	10 Participants n=10 Participants	9 Participants n=9 Participants	19 Participants n=19 Participants
Sex/Gender, Customized Male	6 Participants n=10 Participants	4 Participants n=9 Participants	10 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	10 participants n=10 Participants	9 participants n=9 Participants	19 participants n=19 Participants

PRIMARY outcome

Timeframe: 30 days

Number of patients with post-operative atrial fibrillation

Outcome measures

Measure	1 - Amiodarone n=6 Participants Perioperative amiodarone Amiodarone: Perioperative orally administered Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery	2 - Control n=8 Participants Control arm, standard care with no perioperative amiodarone Control arm, standard care: Control
Incidence of Post-operative Atrial Fibrillation	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 1 week on average

Length of hospital stay after the operation

Outcome measures

Measure	1 - Amiodarone n=6 Participants Perioperative amiodarone Amiodarone: Perioperative orally administered Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery	2 - Control n=8 Participants Control arm, standard care with no perioperative amiodarone Control arm, standard care: Control
Length of Post-operative Hospital Stay	5 Days Standard Deviation 2	5 Days Standard Deviation 4

Adverse Events

1 - Amiodarone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 - Control

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

Min Kim

Houston Methodist Hospital

Phone: 7134415177

Email: mpkim@houstonmethodist.org

Results disclosure agreements

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