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Trial Outcomes & Findings for Prevention of Atrial Fibrillation Following Esophagectomy (NCT NCT00420017)

NCT ID: NCT00420017

Last Updated: 2013-09-18

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

7 days

Results posted on

2013-09-18

Participant Flow

Between September 2004 and November 2008, 80 patients were enrolled in the study, with 40 patients randomized to each arm. Patients were recruited from an academic medical center prior to undergoing esophageal surgery

133 patients were screened for eligibility. 39 were excluded prior to consent d/t presence of exclusion criteria or declined participation. 94 were consented. 14 did not participate: 3 had pre-op exclusion criteria; 4 were withdrawn because the study protocol was delayed; 7 were excluded because they developed intra-operative atrial fibrillation

Participant milestones

Participant milestones
Measure
Amiodarone
Intravenous amiodarone
Control
Control usual care
Overall Study
STARTED
40
40
Overall Study
COMPLETED
38
40
Overall Study
NOT COMPLETED
2
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Atrial Fibrillation Following Esophagectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Amiodarone
n=40 Participants
Intravenous amiodarone
Control
n=40 Participants
Control usual care
Total
n=80 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
22 Participants
n=93 Participants
21 Participants
n=4 Participants
43 Participants
n=27 Participants
Age, Categorical
>=65 years
18 Participants
n=93 Participants
19 Participants
n=4 Participants
37 Participants
n=27 Participants
Age Continuous
61 years
STANDARD_DEVIATION 10 • n=93 Participants
63 years
STANDARD_DEVIATION 9 • n=4 Participants
62 years
STANDARD_DEVIATION 9.5 • n=27 Participants
Sex: Female, Male
Female
6 Participants
n=93 Participants
7 Participants
n=4 Participants
13 Participants
n=27 Participants
Sex: Female, Male
Male
34 Participants
n=93 Participants
33 Participants
n=4 Participants
67 Participants
n=27 Participants
Region of Enrollment
United States
40 participants
n=93 Participants
40 participants
n=4 Participants
80 participants
n=27 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Analysis was per protocol

Outcome measures

Outcome measures
Measure
Amiodarone
n=40 Participants
Intravenous amiodarone
Control
n=40 Participants
Control usual care
Incidence of Atrial Fibrillation
6 participants
16 participants

SECONDARY outcome

Timeframe: Duration of hospitalization

Outcome measures

Outcome measures
Measure
Amiodarone
n=40 Participants
Intravenous amiodarone
Control
n=40 Participants
Control usual care
Length of Post-surgical Hospital Stay
11 days
Interval 9.0 to 15.0
12 days
Interval 9.5 to 15.0

SECONDARY outcome

Timeframe: 7 days

Outcome measures

Outcome measures
Measure
Amiodarone
n=40 Participants
Intravenous amiodarone
Control
n=40 Participants
Control usual care
Length of Post-surgical Intensive Care Unit Stay
68 hours
Interval 38.0 to 124.0
77 hours
Interval 39.0 to 122.0

SECONDARY outcome

Timeframe: 7 days

Population: Per protocol

Adverse effects, including cardiovascular (hypotension, bradycardia, prolonged QT interval, ventricular tachycardia), respiratory (ARDS, pneumonia, atelectasis), and other (pericardial effusions, anastomotic leak)

Outcome measures

Outcome measures
Measure
Amiodarone
n=40 Participants
Intravenous amiodarone
Control
n=40 Participants
Control usual care
Number of Participants With Adverse Effects
21 patients
19 patients

Adverse Events

Amiodarone

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Control

Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Amiodarone
n=40 participants at risk
Intravenous amiodarone
Control
n=40 participants at risk
Control usual care
General disorders
death
0.00%
0/40
5.0%
2/40 • Number of events 2

Other adverse events

Other adverse events
Measure
Amiodarone
n=40 participants at risk
Intravenous amiodarone
Control
n=40 participants at risk
Control usual care
Cardiac disorders
bradycardia
7.5%
3/40 • Number of events 3
2.5%
1/40 • Number of events 1

Additional Information

James E Tisdale PharmD

Purdue University

Phone: 317-613-2315

Results disclosure agreements

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