Effect of Alpha-Lipoic Acid Supplementation on the Incidence of Postoperative Atrial Fibrillation in Cardiac Surgery Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- • Number of Participants with POAF
研究概览
简要总结
ALA is administered orally since it is without difficulty absorbed in the stomach. ALA goes through the blood brain barrier and does not show toxic effects and actions at doses used for prophylactic and therapeutic purposes. This has encouraged us to use an efficient anti-oxidant and anti-inflammatory agent, alpha-lipoic acid (biochemical) as a relevant option to prevent POAF.
详细描述
Investigators computed on the basis of findings from a prior study found the incidence of POAF after cardiac surgery of about 25% . Assuming a slightly lower alpha-lipoic acid' effect to previous study. If the true relative risk of AF for experimental subjects relative to controls is 0.5 , with α equivalent to 0.5 and power (1 - β) is 0.8, the estimated sample size is 152 experimental subjects and 152 control subjects in order to be able to reject the null hypothesis that this relative risk equals 1 with probability (power) of 0.8. investigators used the uncorrected chi-squared statistics to evaluate this null hypothesis. STATA software version and taking into account a possible dropout of 15%, the total sample size was: 304 + 0.15 (304) × 2 = 350 subjects of which there will be 175 controls and 175 experimental subjects %, assuming an enrolment ratio of 1:1.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients above 18 years of age who are scheduled for cardiac surgery.
排除标准
- •Any urgent or emergency surgery.
- •Poor Left ejection volume (EF < 30%).
- •Intake of steroids or any antiarrhythmic drugs except beta blockers during the last month before surgery
- •Unable or unwilling to provide informed written consent.
- •Pregnancy or lactation
- •Known hypersensitivity to the study drug.
- •Current treatment with antioxidants or alpha-lipoic acid for any indication.
- •Infection or inflammatory disease except coronary artery disease.
- •Left atrium size >70 mm.
研究组 & 干预措施
Group 1 (Control group, N = 175 patients)
which will include patients adopted to the hospital standard of care.
干预措施: Placebo (Drug)
Group 2 (Test group, N = 175 patients)
which will include patients who will receive Alpha-lipoic acid (Thiotacid 600 mg ®) at a dose of 600 mg three times daily for one day prior to surgery, followed by Alpha-lipoic acid 600 mg twice daily for 5 days post-surgery plus the standard care.
干预措施: Alpha Lipoic Acid 600 MG Oral Tablet (Drug)
结局指标
主要结局
• Number of Participants with POAF
时间窗: 1 month
次要结局
- 30 days mortality(1-month)
- Serum creatinine(5 days)
- Total hospital length-of-stay(3 months)
- Total intensive care unit length-of-stay(3 months)
- Major adverse cardiovascular outcomes(1 month)
- Duration of ventilation(5 days)