Phase 3
N=304
Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
Atrial Fibrillation · Atrial Flutter
Bottom Line
View on ClinicalTrials.gov: NCT00953212 ↗Enrolled (actual)
304
Serious AEs
2.0%
Results posted
Mar 2018
Primary outcome: Primary: Occurrence of Post-operative Atrial Fibrillation Requiring Treatment After Open Heart Surgery — 50; 56; 58; 48 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- beta blockers (Drug); amiodarone (Drug); ascorbic acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MaineHealth
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Post-operative Atrial Fibrillation Requiring Treatment After Open Heart Surgery |
50; 56; 58; 48 | — |
| SECONDARY Number of Participants With Mortality |
1; 1; 1; 0 | — |
| SECONDARY Hospital Length of Stay |
7.0; 6.6; 6.8; 6.8 | — |
| SECONDARY ICU Length of Stay |
2.0; 1.9; 2.0; 1.9 | — |
| SECONDARY Number of Participants With Stroke |
1; 3; 1; 1 | — |
| SECONDARY Number of Participants With Low Output Heart Failure |
12; 10; 7; 9 | — |
| SECONDARY Number of Participants With Postoperative Vasoplegia |
17; 15; 14; 16 | — |
| SECONDARY Number of Participants With Respiratory Failure Requiring Reintubation |
4; 2; 2; 5 | — |
| SECONDARY Number of Participants With Bradycardia Necessitating Permanent Pacemaker Placement |
0; 2; 0; 2 | — |
| SECONDARY Number of Participants With Acute Kidney Injury |
19; 13; 22; 11 | — |
| SECONDARY Number of Participants With Readmission to ICU for Treatment of Atrial Fibrillation |
1; 1; 2; 0 | — |
| SECONDARY Number of Participants With Readmission to Hospital for Treatment of Atrial Fibrillation |
4; 4; 4; 4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00953212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.