Effects of Oral Nitrate During Coronary Artery Bypass Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Troponin T release over the perioperative 72-hour period.
研究概览
简要总结
The purpose of this study is to determine whether oral sodium nitrate administration prior to coronary artery bypass surgery can reduce perioperative levels of troponin T. In addition, plasma and urine surrogate markers of renal, hepatic and brain injury will be monitored.
详细描述
Nitric oxide (NO) is an important mediator in the cardiovascular system and has been shown to have protective properties in ischemia-reperfusion injury. Inorganic nitrate, an oxidation product from endogenous NO production and also a constituent in green leafy vegetables, can be recycled, via nitrite, back to bioactive NO in the body. Recent research has shown beneficial effects of nitrate and nitrite in animal models of myocardial ischemia-reperfusion injury. Moreover, dietary nitrate reduces blood pressure and oxygen cost during exercise in humans.
During coronary bypass surgery the heart undergoes ischemia-reperfusion injury and troponin T is most often released from the myocardium. The aim of the present study is to investigate if preoperative inorganic nitrate, in doses easily achievable from the diet, can affect troponin T release as well as other surrogate markers of injury to the liver, kidneys and the brain. In addition, plasma and urine samples will be collected for markers of oxidative stress and inflammation (sCRP and cytokines). Patients planned for bypass surgery who give their written informed consent will, the night before surgery, get a standardized, low-nitrate meal where after they receive sodium nitrate on two occasions preoperatively; the night before and in the morning before surgery. Plasma and urine samples will be collected at various time points up to 72 hours after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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 undergoing coronary artery bypass surgery
- •Over 18 years of age
排除标准
- •Over 80 years of age
- •Pregnancy
- •Reoperation
- •Intended heart valve or additional surgery
- •Angina or troponin release above 45 nmol/L < 48 hours before surgery
- •Medication with organic nitrates/nitrites < 24 hours before surgery
- •Medication with glibenclamide or corticosteroids
- •Significant renal, pulmonary or hepatic disease
结局指标
主要结局
Troponin T release over the perioperative 72-hour period.
时间窗: 72 hours
次要结局
- Creatinine kinase myocardial fraction (CKMB) release over the perioperative 24-hour period(24 hours)
- Pro Brain natriuretic peptide (proBNP) release over the perioperative 72-hour period.(72 hours)
- Aspartate aminotransferase (AST) release over the perioperative 72-hour period.(72 hours)
- Alaninaminotransferas (ALAT) release over the perioperative 72-hour period.(72 hours)
- Alkaline phosphatase (ALP) release over the perioperative 72-hour period.(72 hours)
- Bilirubin release over the perioperative 72-hour period(72 hours)
- Troponin T release over the perioperative 24-hour period.(24 h)
- Creatinine kinase myocardial fraction (CKMB) release over the perioperative 72-hour period(72 hours)
- Creatinine release over the perioperative 72-hour period(72 h)
- Cystatin C release over the perioperative 72-hour period(72)
研究者
Eddie Weitzberg
Professor
Karolinska Institutet