Protective Effect of Coenzyme Q10 Against Negative Inflammatory Response and Organ Dysfunction in Cardiac and Aortic Surgery (PANDA V): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- C-reactive protein
研究概览
简要总结
Cardiovascular diseases are the leading causes of death and prescription drug use. Research on certain dietary supplements looks promising as a way to help reduce risk factors. Previous studies showed that CoQ10 levels were decreased in cardiovascular patients and worsening of mitochondrial dysfunction was observed. The overall objective of this study is to determine if supplementing with CoQ10 can reduce inflammatory risk factors in adults with cardiac surgery, independent of other dietary or physical activity changes.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women
- •Who receive cardiovascular surgery
- •Agree to participate in the surgery and sign the informed consent form
排除标准
- •Pregnant or planning on getting pregnant during the study
- •Contain a minimum of 2 traits of metabolic syndrome
- •Refused to participate in the surgery and refused informed consent
研究组 & 干预措施
Coenzyme Q10 group
Participants in the experimental group will be given 10mg of Coenzyme Q10 each time (3 times a day).
干预措施: Coenzyme Q10 (Drug)
Control
patients only receive standard medical therapy.
干预措施: Standard Medical Therapy (Dietary Supplement)
结局指标
主要结局
C-reactive protein
时间窗: Change from baseline of CRP in mg/L at 5 days after surgery.
Inflammatory and endothelial blood work biomarkers
次要结局
- Interleukin-6(Change from baseline of IL-6 in pg/mL at 5 days after surgery.)
研究者
Hong Liu
Investigator of Cardio-Thoracic Surgery
Nanjing Medical University