The Effect of Co-administration of Zinc and Vitamin E Oral Supplements on Short-term Postoperative Outcomes and Plasma Concentrations of Oxidative Stress Biomarkers in Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- ICU LOS
研究概览
简要总结
Cardiac surgery can cause oxidative stress due to ischemia-reperfusion. Using antioxidants during perioperative period may help improve this condition. Vitamin E and zinc have antioxidant effects. In this study, the effects of oral co-administration of zinc and vitamin E supplements on short-term postoperative outcomes in cardiac surgery patients will be investigated.
详细描述
Cardiac surgery is a life-saving invasive procedure that may often be associated with significant postoperative complications. Cardiac surgery can cause oxidative stress due to ischemia-reperfusion. This is a post-ischemic complication that occurs when blood circulation is restored and causes inflammation and oxidative damage. Cardiac surgery with reperfusion injury can adversely affect the prognosis. Thus, reducing the extend of reperfusion injury and its associated pathways can be considered an important clinical issue. Reducing oxidative stress and inflammation may play an important role in the outcomes of heart surgery. Using antioxidants in pre or post surgery may help improve this condition. Vitamin E is a well-known fat-soluble antioxidant that prevents lipid peroxidation. Zinc has several roles including antioxidant effects. Zinc acts as a cofactor for important enzymes that contribute to the proper functioning of the antioxidant defense system. In addition, the mineral is involved in reducing free radicals by inducing metallothionein synthesis and circulating zinc concentration decreases significantly after surgery. In this study, the effects of oral co-administration of zinc and vitamin E supplements shortly before and after surgery on short-term postoperative outcomes, plasma concentrations of biomarkers of oxidative stress and inflammation in patients will be investigated.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are candidates for open heart surgery (coronary artery bypass grafting)
排除标准
- •Frequent use of multivitamin, zinc, vitamin E, vitamin C, omega-3 supplements over the past month
- •Active cancer, chronic rheumatic disease, ESRD, liver cirrhosis, severe infection (WBC> 12000 mm3) before surgery
- •Continued use of corticosteroids or NSAIDs for two weeks prior to admission (except A.S.A)
结局指标
主要结局
ICU LOS
时间窗: Through study completion, an average of 5 days
Duration of patients' stay in the intensive care unit
Post surgery hospital LOS
时间窗: Through study completion, an average of 10 days
Duration of patients' stay in the hospital
次要结局
- The sequential organ failure assessment score(On the third day after surgery)
- Plasma total antioxidant(up to 3 days after surgery)
- Plasma superoxide dismutase activity(up to 3 days after surgery)
- Plasma CRP(up to 3 days after surgery)
研究者
Javad Nasrollahzadeh
Associate Professor
Shahid Beheshti University of Medical Sciences