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Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery

Primary Purpose

Atrial Fibrillation, Atrial Flutter

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
beta blockers
amiodarone
ascorbic acid
Sponsored by
MaineHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, cardiac surgery, open heart surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maine Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

Beta Blockers, Ascorbic Acid and Amiodarone

Beta Blockers and Ascorbic Acid

Beta Blockers and Amiodarone

Beta Blockers alone

Outcomes

Primary Outcome Measures

Occurrence of Post-operative Atrial Fibrillation Requiring Treatment After Open Heart Surgery
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

Number of Participants With Mortality
Mortality measured within length of hospital stay
Hospital Length of Stay
ICU Length of Stay
Number of Participants With Stroke
Cerebral vascular accident occurring within hospital length of stay
Number of Participants With Low Output Heart Failure
Number of Participants With Postoperative Vasoplegia
Number of Participants With Respiratory Failure Requiring Reintubation
Number of Participants With Bradycardia Necessitating Permanent Pacemaker Placement
Number of Participants With Acute Kidney Injury
Using the Akin definition
Number of Participants With Readmission to ICU for Treatment of Atrial Fibrillation
Number of Participants With Readmission to Hospital for Treatment of Atrial Fibrillation

Full Information

First Posted
August 5, 2009
Last Updated
March 28, 2018
Sponsor
MaineHealth
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1. Study Identification

Unique Protocol Identification Number
NCT00953212
Brief Title
Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MaineHealth

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter
Keywords
atrial fibrillation, cardiac surgery, open heart surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Beta Blockers, Ascorbic Acid and Amiodarone
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Beta Blockers and Ascorbic Acid
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Beta Blockers and Amiodarone
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Beta Blockers alone
Intervention Type
Drug
Intervention Name(s)
beta blockers
Other Intervention Name(s)
Lopressor, Toprol XL
Intervention Description
metoprolol 25mg by mouth every 6 hours
Intervention Type
Drug
Intervention Name(s)
amiodarone
Other Intervention Name(s)
Cordarone
Intervention Description
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
Intervention Name(s)
ascorbic acid
Other Intervention Name(s)
vitamin C
Intervention Description
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
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Number of Participants With Mortality
Description
Mortality measured within length of hospital stay
Time Frame
30 days
Title
Hospital Length of Stay
Time Frame
30 days
Title
ICU Length of Stay
Time Frame
30 days
Title
Number of Participants With Stroke
Description
Cerebral vascular accident occurring within hospital length of stay
Time Frame
30 days
Title
Number of Participants With Low Output Heart Failure
Time Frame
30 days
Title
Number of Participants With Postoperative Vasoplegia
Time Frame
30 days
Title
Number of Participants With Respiratory Failure Requiring Reintubation
Time Frame
30 days
Title
Number of Participants With Bradycardia Necessitating Permanent Pacemaker Placement
Time Frame
30 days
Title
Number of Participants With Acute Kidney Injury
Description
Using the Akin definition
Time Frame
30 days
Title
Number of Participants With Readmission to ICU for Treatment of Atrial Fibrillation
Time Frame
30 days
Title
Number of Participants With Readmission to Hospital for Treatment of Atrial Fibrillation
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter C Donovan, PA-C, MHS
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert S Kramer, M.D.
Organizational Affiliation
MaineHealth
Official's Role
Study Chair
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States

12. IPD Sharing Statement

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Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery

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