Atrial Fibrillation New Onset
Conditions
Keywords
cardiac surgery, postoperative atrial fibrillation, silymarin
Brief summary
The study is a prospective, randomized, controlled trial to assess the effects of silymarin on the occurrence of postoperative atrial fibrillation after coronary artery bypass graft surgery.
Detailed description
Postoperative atrial fibrillation (POAF) is a frequent complication after coronary artery bypass graft (CABG) surgery and is associated with increased mortality. So far, the effects of various drugs and supplements on the occurrence of postoperative atrial fibrillation (POAF) have been studied, but no one has looked into the effect of silymarin on the occurrence of POAF. The study is designed as a prospective, randomized, controlled trial to assess the effects of silymarin on the occurrence of postoperative atrial fibrillation after CABG surgery. A total of 160 patients of both sexes scheduled for elective CABG surgery using cardiopulmonary bypass (CPB) will be included. They will be randomized into two groups (experimental and control) with 80 patients each. Subjects in the experimental group will receive 400 mg of silymarin three days preoperatively, while subjects in the control group will receive standard therapy. The occurrence of POAF after CABG surgery will be the primary outcome, which will be defined as any dysrhythmia that represents the ECG characteristics of atrial fibrillation lasting at least 30 s on a rhythm strip or 12-lead ECG. Secondary outcomes will include postoperative values of inflammation markers, length of stay in the ICU, length of hospitalization, and occurrence of postoperative complications (pericardial effusion, stroke, in-hospital death).
Interventions
DRUGSilymarin
Subjects of the experimental group will receive silymarin (capsules containing 100 mg silymarin, expressed as silibinin) three days preoperatively. The dose they receive will be the recommended dose for the registered indications (400 mg daily, orally, divided into two doses).
Sponsors
University of Novi Sad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* scheduled for elective CABG surgery using cardiopulmonary bypass * first cardiac surgery * left ventricular ejection fraction \> 35% * less than moderate mitral regurgitation
Exclusion criteria
* preoperative atrial fibrillation * previous history of interventionally treated arrhythmias * end-stage renal disease requiring hemodialysis * chronic inflammatory and neoplastic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with postoperative atrial fibrillation | 4 days | Occurrence of postoperative atrial fibrillation lasting at least 30 s on a rhythm strip or 12-lead ECG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU length of stay | 30 days | Total duration of stay in the intensive care unit |
| Hospital length of stay | 30 days | Total duration of stay in hospital |
| Postoperative complications | 30 days | Occurrence of postoperative complications including pericardial effusion, stroke, and in-hospital death |
| Blood concentration of white blood cells | 4 days | Postoperative values of white blood cells |
| Blood concentration of C-reactive protein | 4 days | Postoperative values of C-reactive protein |
Countries
Serbia
Outcome results
None listed