NCT00839085Unknown不适用
Effect of Ascorbic Acid and Grape Seed Extract "Vitis Vinifera L." in Oxidative Stress Induced by on Pump Coronary Artery by Pass Grafting Surgery
Tabriz University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- LVEF
研究概览
简要总结
Study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.
详细描述
This study aimed to compare the effect of grape seed extract and ascorbic acid in oxidative stress induced by on pump coronary artery by pass grafting surgery.
There are three groups in the study. 75 candidate of coronary artery by pass grafting surgery were assigned random allocation on the groups (25 in each group).
- Control
- GSE (100 mg/6h - PO, 24h before surgery)
- Vit C (25 mg/kg in pump circulation during surgery)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates for elective CABG surgery with pump for first time
排除标准
- •High risk patients
- •Those who need another heart surgery beside CABG
- •Urgent patients
- •Diabetics
- •Ischemic time more than 120 min
研究组 & 干预措施
2: GSE
Active Comparator
100 mg GSE every 6h /Po, starting one day before surgery (4 doses in 24h)
干预措施: GSE (Drug)
3: Vit C
Active Comparator
25 mg/kg through pump
干预措施: Vit C (Ascorbic Acid) (Drug)
结局指标
主要结局
LVEF
时间窗: Before and after CABG
次要结局
- Total Antioxidant Capacity (TAC)(Before ischemia, after ischemia, after reperfusion)
- MDA(Before, middle and after CABG)
- GTX(Before ischemia, after ischemia, after reperfusion)
- SOD(Before ischemia, after ischemia, after reperfusion)
研究者
研究点 (1)
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