Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery

• Sponsor: MaineHealth (Other)
• Overall Status: Completed
• CT.gov ID: NCT00953212
• Collaborator: (none)
• Enrollment: 304
• Location: 1
• Arms: 4
• Duration (Months): 30
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

Atrial Fibrillation (AF) is a common postoperative complication of cardiac surgery, occuring in approximately 25-30% of coronary artery bypass graft (CABG) patients and 35-40% of heart valve repair/replacement patients. Efforts to decrease the high rates of AF have not made great inroads to the problem. The current standard of care is the use of preoperative and postoperative beta blockers. We propose to compare the use of prophylactic oral ascorbic acid with and without prophylactic oral amiodarone, in combination with oral beta blockers, for the prevention of atrial fibrillation after open heart surgery. The hypothesis is that either drug, or a combination of the two drugs, will be superior and safe when compared to beta blockers alone.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Atrial Flutter	Drug: beta blockers; Drug: amiodarone; Drug: ascorbic acid	Phase 3

Detailed Description

Atrial fibrillation is a common complication of cardiac surgery which is associated with increased morbidity, length of stay and cost. Efforts to mitigate this problem with beta blockers and amiodarone have been met with limited success. Observational data suggests that prophylactic amiodarone has been helpful in decreasing the incidence of AF as well as increasing its ease of management. The opportunity to use ascorbic acid for AF prophylaxis is attractive because of its low side effect profile, wide acceptance and low cost.

We have designed a prospective, randomized, controlled trial using a 2 X 2 factorial design to determine whether prophylactic ascorbic acid alone, ascorbic acid with amiodarone, or amiodarone alone, when given along with beta blockers will decrease the incidence of postoperative AF in adult cardiac surgery in all comers as compared with beta blockers alone.

Patients will be randomized into four groups, A, B, C, and D. All groups will receive beta blockers, Group A will receive beta blockers, ascorbic acid, and amiodarone, Group B will receive ascorbic acid and Beta blockers, Group C will receive amiodarone and beta blockers and Group D will receive only beta blockers.

Success of randomization will be assessed by comparing treatment groups with respect to baseline characteristics, using t-tests or their nonparametric equivalent (as appropriate) for continuous variables and chisquare tests or Fisher's exact tests for categorical variables. The primary hypotheses of the effects of ascorbic acid and amiodarone on incidence of atrial fibrillation will be tested using chisquare tests for differences in proportions. No adjustment will be made for multiple comparisons since both hypotheses are pre-specified. We will use exploratory analyses including stratification to assess for the possibility of effect modification between ascorbic acid and amiodarone. If an interaction is suggested by these analyses, we will use logistic regression with a cross-product term as a formal statistical test for interaction.

Study Design

• Study Type: Interventional
• Actual Enrollment: 304 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized Controlled Trial to Compare Prophylaxis With Oral Ascorbic Acid, Oral Amiodarone or Both in Combination With Beta Blockers to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A Beta Blockers, Ascorbic Acid and Amiodarone	Drug: beta blockers; metoprolol 25mg by mouth every 6 hours; Other Names: Lopressor Toprol XL ; Drug: amiodarone; amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively; Other Names: Cordarone ; Drug: ascorbic acid; ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days; Other Names: vitamin C
Active Comparator: Group B Beta Blockers and Ascorbic Acid	Drug: beta blockers; metoprolol 25mg by mouth every 6 hours; Other Names: Lopressor Toprol XL ; Drug: ascorbic acid; ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days; Other Names: vitamin C
Active Comparator: Group C Beta Blockers and Amiodarone	Drug: beta blockers; metoprolol 25mg by mouth every 6 hours; Other Names: Lopressor Toprol XL ; Drug: amiodarone; amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively; Other Names: Cordarone
Active Comparator: Group D Beta Blockers alone	Drug: beta blockers; metoprolol 25mg by mouth every 6 hours; Other Names: Lopressor Toprol XL

Outcome Measures

Primary Outcome Measures

1. Occurrence of Post-operative Atrial Fibrillation Requiring Treatment After Open Heart Surgery [5 postoperative days]

   Atrial fibrillation is a common complication of cardiac surgery which is associated with increased morbidity, length of stay and cost. The opportunity to use ascorbic acid for AF prophylaxis is attractive because of its low side effect profile, wide acceptance and low cost. This prospective, randomized trial used a 2 X 2 factorial design to determine whether prophylactic ascorbic acid alone, ascorbic acid with amiodarone, or amiodarone alone, when given along with beta blockers would decrease the incidence of postoperative AF in adult cardiac surgery when compared with beta blockers alone, all combinations failed to show any difference between the four groups. While there have been trials that have shown the addition of amiodarone to beta-blockers to be more effective, this analysis does not support that conclusion.

Secondary Outcome Measures

1. Number of Participants With Mortality [30 days]

   Mortality measured within length of hospital stay

2. Hospital Length of Stay [30 days]

3. ICU Length of Stay [30 days]

4. Number of Participants With Stroke [30 days]

   Cerebral vascular accident occurring within hospital length of stay

5. Number of Participants With Low Output Heart Failure [30 days]

6. Number of Participants With Postoperative Vasoplegia [30 days]

7. Number of Participants With Respiratory Failure Requiring Reintubation [30 days]

8. Number of Participants With Bradycardia Necessitating Permanent Pacemaker Placement [30 days]

9. Number of Participants With Acute Kidney Injury [30 days]

   Using the Akin definition

10. Number of Participants With Readmission to ICU for Treatment of Atrial Fibrillation [30 days]

11. Number of Participants With Readmission to Hospital for Treatment of Atrial Fibrillation [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adults (18 years of age or older)

• all comers for elective or urgent open heart surgery ( CABG, Valve repair or replacement, Combined CABG/Valves, CABG/other, Other)

Exclusion Criteria:

• patients who refuse to participate

• patients with a history of atrial fibrillation or atrial flutter

• pediatric patients (under 18 years of age)

• Emergency surgery

• patients with contraindications to study medications

• patients with untreated thyroid disease, hepatic failure, pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maine Medical Center	Portland	Maine	United States	04102

Sponsors and Collaborators

• MaineHealth

Investigators

• Principal Investigator: Peter C Donovan, PA-C, MHS, MaineHealth
• Study Chair: Robert S Kramer, M.D., MaineHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter C. Donovan, Staff Physician Assistant, Cardiothoracic Surgery, MaineHealth
• ClinicalTrials.gov Identifier: NCT00953212
• Other Study ID Numbers: MMC-3514
• First Posted: Aug 6, 2009
• Last Update Posted: Apr 26, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by Peter C. Donovan, Staff Physician Assistant, Cardiothoracic Surgery, MaineHealth: atrial fibrillation; cardiac surgery; open heart surgery
• Additional relevant MeSH terms: Atrial Fibrillation; Atrial Flutter; Ascorbic Acid; Amiodarone; Metoprolol; Adrenergic beta-Antagonists

Study Results

Participant Flow

Arm/Group Title	Beta Blockers, Ascorbic Acid and Amiodarone	Beta Blockers and Ascorbic Acid	Beta Blockers and Amiodarone	Beta Blockers Alone
Arm/Group Description	beta blockers: metoprolol 25mg by mouth every 6 hours amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days	Beta Blockers and Ascorbic Acid beta blockers: metoprolol 25mg by mouth every 6 hours ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days	Beta Blockers and Amiodarone beta blockers: metoprolol 25mg by mouth every 6 hours amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively	Beta Blockers alone beta blockers: metoprolol 25mg by mouth every 6 hours
Period Title: Overall Study
STARTED	76	74	78	76
COMPLETED	76	74	78	76
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Group A	Group B	Group C	Group D	Total
Arm/Group Description	Beta Blockers, Ascorbic Acid and Amiodarone beta blockers: metoprolol 25mg by mouth every 6 hours amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days	Beta Blockers and Ascorbic Acid beta blockers: metoprolol 25mg by mouth every 6 hours ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days	Beta Blockers and Amiodarone beta blockers: metoprolol 25mg by mouth every 6 hours amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively	Beta Blockers alone beta blockers: metoprolol 25mg by mouth every 6 hours	Total of all reporting groups
Overall Participants	76	74	78	76	304
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.3 (9.6)	65.9 (9.4)	63.9 (10.7)	33.4 (931)	61 (15)
Sex: Female, Male (Count of Participants)
Female	16 21.1%	19 25.7%	19 24.4%	20 26.3%	74 24.3%
Male	60 78.9%	55 74.3%	59 75.6%	56 73.7%	230 75.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	1 1.3%	1 0.3%
White	76 100%	74 100%	77 98.7%	75 98.7%	302 99.3%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	1 1.3%	0 0%	1 0.3%
Smoker (Count of Participants)
Count of Participants [Participants]	16 21.1%	19 25.7%	21 26.9%	19 25%	75 24.7%
BMI (mean, SD) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.6 (6.1)	31.1 (5.7)	27.9 (4.7)	29.5 (6.2)	29.7 (5.8)
Cardiovascular Disease (Count of Participants)
Count of Participants [Participants]	11 14.5%	13 17.6%	14 17.9%	13 17.1%	51 16.8%
Hypertension (Count of Participants)
Count of Participants [Participants]	69 90.8%	63 85.1%	62 79.5%	65 85.5%	259 85.2%
Pre-op Myocardial Infarction (Count of Participants)
Count of Participants [Participants]	24 31.6%	30 40.5%	29 37.2%	35 46.1%	118 38.8%
Diabetes (Count of Participants)
Count of Participants [Participants]	28 36.8%	28 37.8%	23 29.5%	27 35.5%	106 34.9%
Peripheral Vascular Disease (Count of Participants)
Count of Participants [Participants]	10 13.2%	8 10.8%	9 11.5%	10 13.2%	37 12.2%
Chronic Obstructive Pulmonary Disease (Count of Participants)
Count of Participants [Participants]	10 13.2%	7 9.5%	3 3.8%	11 14.5%	31 10.2%
Statin (Count of Participants)
Count of Participants [Participants]	54 71.1%	50 67.6%	52 66.7%	47 61.8%	203 66.8%
Congestive Heart Failure (Count of Participants)
Count of Participants [Participants]	6 7.9%	8 10.8%	4 5.1%	8 10.5%	26 8.6%
Surgery Type - CABG (Count of Participants)
Count of Participants [Participants]	62 81.6%	57 77%	55 70.5%	58 76.3%	232 76.3%
Surgery Type - Valve (Count of Participants)
Count of Participants [Participants]	6 7.9%	6 8.1%	13 16.7%	3 3.9%	28 9.2%
Surgery Type - CABG/Valve (Count of Participants)
Count of Participants [Participants]	6 7.9%	9 12.2%	9 11.5%	12 15.8%	36 11.8%
Surgery Type - Other (Count of Participants)
Count of Participants [Participants]	2 2.6%	2 2.7%	1 1.3%	3 3.9%	8 2.6%
Urgent Surgery (Count of Participants)
Count of Participants [Participants]	68 89.5%	72 97.3%	71 91%	73 96.1%	284 93.4%

Outcome Measures

1. Primary Outcome

Title	Occurrence of Post-operative Atrial Fibrillation Requiring Treatment After Open Heart Surgery
Description	Atrial fibrillation is a common complication of cardiac surgery which is associated with increased morbidity, length of stay and cost. The opportunity to use ascorbic acid for AF prophylaxis is attractive because of its low side effect profile, wide acceptance and low cost. This prospective, randomized trial used a 2 X 2 factorial design to determine whether prophylactic ascorbic acid alone, ascorbic acid with amiodarone, or amiodarone alone, when given along with beta blockers would decrease the incidence of postoperative AF in adult cardiac surgery when compared with beta blockers alone, all combinations failed to show any difference between the four groups. While there have been trials that have shown the addition of amiodarone to beta-blockers to be more effective, this analysis does not support that conclusion.
Time Frame	5 postoperative days

Outcome Measure Data

Analysis Population Description

Number of patients who experienced Atrial Fibrillation post-operatively

Arm/Group Title	Amiodarone - Yes	Amiodarone - No	Ascorbic Acid - Yes	Ascorbic Acid - No
Arm/Group Description	Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.	Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
Measure Participants	154	150	150	154
Count of Participants [Participants]	50 65.8%	56 75.7%	58 74.4%	48 63.2%

2. Secondary Outcome

Title	Number of Participants With Mortality
Description	Mortality measured within length of hospital stay
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Beta Blockers, Ascorbic Acid and Amiodarone	Beta Blockers and Ascorbic Acid	Beta Blockers and Amiodarone	Beta Blockers Alone
Arm/Group Description	beta blockers: metoprolol 25mg by mouth every 6 hours amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days	Beta Blockers and Ascorbic Acid beta blockers: metoprolol 25mg by mouth every 6 hours ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days	Beta Blockers and Amiodarone beta blockers: metoprolol 25mg by mouth every 6 hours amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively	Beta Blockers alone beta blockers: metoprolol 25mg by mouth every 6 hours
Measure Participants	154	150	150	154
Count of Participants [Participants]	1 1.3%	1 1.4%	1 1.3%	0 0%

3. Secondary Outcome

Title	Hospital Length of Stay
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Amiodarone - Yes	Amiodarone - No	Ascorbic Acid - Yes	Ascorbic Acid - No
Arm/Group Description	Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.	Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
Measure Participants	154	150	150	154
Mean (Standard Deviation) [days]	7.0 (4.8)	6.6 (3.8)	6.8 (3.6)	6.8 (4.9)

4. Secondary Outcome

Title	ICU Length of Stay
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Amiodarone - Yes	Amiodarone - No	Ascorbic Acid - Yes	Ascorbic Acid - No
Arm/Group Description	Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.	Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
Measure Participants	154	150	150	154
Mean (Standard Deviation) [days]	2.0 (1.5)	1.9 (1.3)	2.0 (1.3)	1.9 (1.5)

5. Secondary Outcome

Title	Number of Participants With Stroke
Description	Cerebral vascular accident occurring within hospital length of stay
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Amiodarone - Yes	Amiodarone - No	Ascorbic Acid - Yes	Ascorbic Acid - No
Arm/Group Description	Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.	Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
Measure Participants	154	150	150	154
Count of Participants [Participants]	1 1.3%	3 4.1%	1 1.3%	1 1.3%

6. Secondary Outcome

Title	Number of Participants With Low Output Heart Failure
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Amiodarone - Yes	Amiodarone - No	Ascorbic Acid - Yes	Ascorbic Acid - No
Arm/Group Description	Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.	Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
Measure Participants	154	150	150	154
Count of Participants [Participants]	12 15.8%	10 13.5%	7 9%	9 11.8%

7. Secondary Outcome

Title	Number of Participants With Postoperative Vasoplegia
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Amiodarone - Yes	Amiodarone - No	Ascorbic Acid - Yes	Ascorbic Acid - No
Arm/Group Description	Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.	Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
Measure Participants	154	150	150	154
Count of Participants [Participants]	17 22.4%	15 20.3%	14 17.9%	16 21.1%

8. Secondary Outcome

Title	Number of Participants With Respiratory Failure Requiring Reintubation
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Amiodarone - Yes	Amiodarone - No	Ascorbic Acid - Yes	Ascorbic Acid - No
Arm/Group Description	Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.	Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
Measure Participants	154	150	150	154
Count of Participants [Participants]	4 5.3%	2 2.7%	2 2.6%	5 6.6%

9. Secondary Outcome

Title	Number of Participants With Bradycardia Necessitating Permanent Pacemaker Placement
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Amiodarone - Yes	Amiodarone - No	Ascorbic Acid - Yes	Ascorbic Acid - No
Arm/Group Description	Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.	Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
Measure Participants	154	150	150	154
Count of Participants [Participants]	0 0%	2 2.7%	0 0%	2 2.6%

10. Secondary Outcome

Title	Number of Participants With Acute Kidney Injury
Description	Using the Akin definition
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Amiodarone - Yes	Amiodarone - No	Ascorbic Acid - Yes	Ascorbic Acid - No
Arm/Group Description	Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.	Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
Measure Participants	154	150	150	154
Count of Participants [Participants]	19 25%	13 17.6%	22 28.2%	11 14.5%

11. Secondary Outcome

Title	Number of Participants With Readmission to ICU for Treatment of Atrial Fibrillation
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Amiodarone - Yes	Amiodarone - No	Ascorbic Acid - Yes	Ascorbic Acid - No
Arm/Group Description	Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.	Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
Measure Participants	154	150	150	154
Count of Participants [Participants]	1 1.3%	1 1.4%	2 2.6%	0 0%

12. Secondary Outcome

Title	Number of Participants With Readmission to Hospital for Treatment of Atrial Fibrillation
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Amiodarone - Yes	Amiodarone - No	Ascorbic Acid - Yes	Ascorbic Acid - No
Arm/Group Description	Patients who were administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were not administered Amiodarone and Beta Blockers with or without Ascorbic Acid.	Patients who were administered Ascorbic Acid and Beta Blockers with or without Amiodarone.	Patients who were not administered Ascorbic Acid and Beta Blockers with or without Amiodarone.
Measure Participants	154	150	150	154
Count of Participants [Participants]	4 5.3%	4 5.4%	4 5.1%	4 5.3%

Adverse Events

Arm/Group Title	Group A		Group B		Group C		Group D
Arm/Group Description	Beta Blockers, Ascorbic Acid and Amiodarone beta blockers: metoprolol 25mg by mouth every 6 hours amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days		Beta Blockers and Ascorbic Acid beta blockers: metoprolol 25mg by mouth every 6 hours ascorbic acid: ascorbic acid 2,000mg by mouth evening before surgery ascorbic acid 2,000mg by mouth morning of surgery ascorbic acid 1,000mg by mouth every 12 hours for 5 postoperative days		Beta Blockers and Amiodarone beta blockers: metoprolol 25mg by mouth every 6 hours amiodarone: amiodarone 600mg by mouth evening before surgery amiodarone 600mg by mouth morning of surgery amiodarone 400mg by mouth every 12 hours for 3 days postoperatively		Beta Blockers alone beta blockers: metoprolol 25mg by mouth every 6 hours
All Cause Mortality
	Group A		Group B		Group C		Group D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/76 (1.3%)		1/74 (1.4%)		1/78 (1.3%)		0/76 (0%)
Serious Adverse Events
	Group A		Group B		Group C		Group D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/76 (1.3%)		3/74 (4.1%)		1/78 (1.3%)		1/76 (1.3%)
Nervous system disorders
Cerebral Vascular Accident	1/76 (1.3%)	1	3/74 (4.1%)	3	1/78 (1.3%)	1	1/76 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Group A		Group B		Group C		Group D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	29/76 (38.2%)		29/74 (39.2%)		21/78 (26.9%)		27/76 (35.5%)
Cardiac disorders
Atrial fibrillation	29/76 (38.2%)	29	29/74 (39.2%)	29	21/78 (26.9%)	21	27/76 (35.5%)	27

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.