Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Atrial Flutter |
Drug: beta blockers Drug: amiodarone Drug: ascorbic acid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (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 |
- Occurence of post-operative atrial fibrillation requiring treatment after open heart surgery [ Time Frame: 5 postoperative days ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Hospital Length of Stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- ICU Length of Stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Stroke [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Low Output Heart Failure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Postoperative Vasoplegia [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Respiratory Failure requiring reintubation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Bradycardia necessitating permanent pacemaker placement [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Acute Kidney Injury [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Readmission to ICU for treatment of atrial fibrillation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Readmission to hospital for treatment of atrial fibrillation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Enrollment: | 304 |
| Study Start Date: | August 2009 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group A
Beta Blockers, Ascorbic Acid and Amiodarone
|
Drug: beta blockers
metoprolol 25mg by mouth every 6 hours
Other Names:
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 Name: 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 Name: vitamin C
|
|
Active Comparator: Group B
Beta Blockers and Ascorbic Acid
|
Drug: beta blockers
metoprolol 25mg by mouth every 6 hours
Other Names:
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 Name: vitamin C
|
|
Active Comparator: Group C
Beta Blockers and Amiodarone
|
Drug: beta blockers
metoprolol 25mg by mouth every 6 hours
Other Names:
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 Name: Cordarone
|
|
Active Comparator: Group D
Beta Blockers alone
|
Drug: beta blockers
metoprolol 25mg by mouth every 6 hours
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| Principal Investigator: | Peter C Donovan, PA-C, MHS | Maine Medical Center |
| Study Chair: | Robert S Kramer, M.D. | Maine Medical Center |
More Information
No publications provided
| Responsible Party: | Peter C. Donovan, Staff Physician Assistant, Cardiothoracic Surgery, Maine Medical Center |
| ClinicalTrials.gov Identifier: | NCT00953212 History of Changes |
| Other Study ID Numbers: | MMC-3514 |
| Study First Received: | August 5, 2009 |
| Last Updated: | May 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Maine Medical Center:
|
atrial fibrillation cardiac surgery open heart surgery |
Additional relevant MeSH terms:
|
Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Adrenergic beta-Antagonists Amiodarone Ascorbic Acid Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Enzyme Inhibitors Vasodilator Agents Antioxidants Protective Agents Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013