Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation Atrial Flutter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Group A

Beta Blockers, Ascorbic Acid and Amiodarone

Group Type ACTIVE_COMPARATOR

beta blockers

Intervention Type DRUG

metoprolol 25mg by mouth every 6 hours

amiodarone

Intervention Type DRUG

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

Intervention Type DRUG

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

Group B

Beta Blockers and Ascorbic Acid

Group Type ACTIVE_COMPARATOR

beta blockers

Intervention Type DRUG

metoprolol 25mg by mouth every 6 hours

ascorbic acid

Intervention Type DRUG

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

Group C

Beta Blockers and Amiodarone

Group Type ACTIVE_COMPARATOR

beta blockers

Intervention Type DRUG

metoprolol 25mg by mouth every 6 hours

amiodarone

Intervention Type DRUG

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

Group D

Beta Blockers alone

Group Type ACTIVE_COMPARATOR

beta blockers

Intervention Type DRUG

metoprolol 25mg by mouth every 6 hours

Interventions

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beta blockers

metoprolol 25mg by mouth every 6 hours

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Lopressor Toprol XL Cordarone vitamin C

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No