Randomized Double Blind Study of Administration of Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Atrial Fibrillation
研究概览
简要总结
The purpose of this study is to determine whether vitamin C is effective in the prophylaxis of post-operative atrial fibrillation in on-pump cardiac surgery
详细描述
Atrial fibrillation (AF) is the single most common post-operative complication after on-pump cardiac surgery, ranging from roughly 25% in CABG procedures, up to 65% in valve replacement procedures. The presence of AF in cardiac surgery patients doubles the morbidity amongst these patients, as well as raising the mortality rates. VitC is an electron donor for a number of enzymatic systems, reducing potentially harmful free radicals. In post-procedural AF, there is increased peroxynitrite concentration, which is a target for vitamin C. A randomized, double blind study will be conducted in order to establish the efficiency of vitamin C as prophylaxis for postoperative AF.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing on-pump cardiac surgery
排除标准
- •Off-pump cardiac surgery procedure
- •AF before the procedure
- •Recent infection and/or infectious endocarditis
- •Presence of neoplasia
- •Chronic renal failure with creatinine>2.3 mg/dl
- •Hepatic failure
- •Autoimmune disease and/or disease that brings about a systematic inflammatory response
- •Thyroid disease
- •Systematic use of supplements that contain vitC or carnitine
- •The use of NSAIDs other than aspirin for a time period up to one month before the procedure
研究组 & 干预措施
L-Carnitine
L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days
干预措施: L-Carnitine (Drug)
Vitamin C
VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days
干预措施: Vitamin C (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Postoperative Atrial Fibrillation
时间窗: Within the first 30 days (plus or minus 3 days)
The incidence of postoperative atrial fibrillation in cardiac surgery patients, using 2 different prophylaxis regimens with vitamin C, as compared to placebo.
次要结局
未报告次要终点
研究者
Polymeropoulos Evangelos
Dr
Attikon Hospital