跳至主要内容
临床试验/NCT06114719
NCT06114719已完成3 期

The Effect of Silymarin on the Prevention of Atrial Fibrillation After Coronary Artery Bypass Graft Surgery

University of Novi Sad1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
160
试验地点
1
主要终点
Number of participants with postoperative atrial fibrillation

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled for elective CABG surgery using cardiopulmonary bypass
  • first cardiac surgery
  • left ventricular ejection fraction > 35%
  • less than moderate mitral regurgitation

排除标准

  • preoperative atrial fibrillation
  • previous history of interventionally treated arrhythmias
  • end-stage renal disease requiring hemodialysis
  • chronic inflammatory and neoplastic diseases

研究组 & 干预措施

Experimental group

Experimental

Silymarin 400 mg daily, orally, divided into two doses, for three days preoperatively

干预措施: Silymarin (Drug)

结局指标

主要结局

Number of participants with postoperative atrial fibrillation

时间窗: 4 days

Occurrence of postoperative atrial fibrillation lasting at least 30 s on a rhythm strip or 12-lead ECG

次要结局

  • ICU length of stay(30 days)
  • Hospital length of stay(30 days)
  • Postoperative complications(30 days)
  • Blood concentration of white blood cells(4 days)
  • Blood concentration of C-reactive protein(4 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mihaela Preveden

Principal investigator

University of Novi Sad

研究点 (1)

Loading locations...

相似试验