Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery

NCT00953212 | Completed Phase 3 Results DMC

• 1 other identifier: MMC-3514
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Keywords

atrial fibrillation; cardiac surgery; open heart surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  5 postoperative days

Secondary Outcomes (11)

• Number of Participants With Mortality

  30 days

• Hospital Length of Stay

  30 days

• ICU Length of Stay

  30 days

• Number of Participants With Stroke

  30 days

• Number of Participants With Low Output Heart Failure

  30 days

Study Arms (4)

Group A

ACTIVE COMPARATOR

Beta Blockers, Ascorbic Acid and Amiodarone

Drug: beta blockers; Drug: amiodarone; Drug: ascorbic acid

Group B

ACTIVE COMPARATOR

Beta Blockers and Ascorbic Acid

Drug: beta blockers; Drug: ascorbic acid

Group C

ACTIVE COMPARATOR

Beta Blockers and Amiodarone

Drug: beta blockers; Drug: amiodarone

Group D

ACTIVE COMPARATOR

Beta Blockers alone

Drug: beta blockers

Interventions

beta blockers DRUG

metoprolol 25mg by mouth every 6 hours

Also known as: Lopressor, Toprol XL

Group A; Group B; Group C; Group D

amiodarone 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

Also known as: Cordarone

Group A; Group C

ascorbic acid 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

Also known as: vitamin C

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

Maine Medical Center

Portland, Maine, 04102, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Interventions

Adrenergic beta-Antagonists; Metoprolol; Amiodarone; Ascorbic Acid

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Dr. Robert Kramer
• Organization: Maine Medical Center

KRAMER@mmc.org

207-662-2923

Study Officials

• Peter C Donovan, PA-C, MHS

  MaineHealth

  PRINCIPAL INVESTIGATOR

• Robert S Kramer, M.D.

  MaineHealth

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician Assistant, Cardiothoracic Surgery

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 26, 2018
• Results First Posted: March 29, 2018

Record last verified: 2018-03

Locations

US (1)