The Effect of Adenosine on Myocardial Protection in Intermittent Warm Blood Cardioplegia: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 6-hour cardiac Troponin T (cTnT) release
研究概览
简要总结
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia, has an added value remains unclear. Therefore the investigators would like to investigate the effect of the addition of adenosine to standard intermittent warm blood cardioplegia in patients scheduled for minimally invasive, port access operations (mitral valve surgery).
Half of the participants will receive standard intermittent warm blood cardioplegia, while the other half will receive intermittent warm blood cardioplegia enriched with adenosine.
详细描述
Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia, has an added value remains unclear. Therefore the investigators would like to investigate whether the addition of adenosine to standard intermittent warm blood cardioplegia reduces the 6-hours post-operative cardiac troponin T (cTnT) in patients scheduled for minimally invasive, port access operations (mitral valve surgery).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective cardiac surgical patients
- •minimally invasive, port access surgery (mitral valve surgery)
排除标准
- •All non-minimally invasive, port access surgery
- •Theophylline or dipyridamole use up to 24 hours prior to surgery
- •Products that contain caffeine of theobromine up to 12 hours prior to surgery (coffee, chocolate, energizing drinks (e.g. Red Bull), tea, soda (coke), etc)
研究组 & 干预措施
adenosine enriched cardioplegia
Delivery of cardioplegic solutions will be according to the standard protocol (Amphia hospital, Breda, the Netherlands). Oxygenated blood and cardioplegic maintenance solution is delivered in a 20:1 ratio. Cardioplegic solutions will be administered at 20-minutes intervals. The flow of the cardioplegia must be at 300 ml/min, the duration is approximately 1 minute.
The cardioplegic maintenance solution consists of a 1000 mg = 500 ml adenosine infusion bag (2 mg/ml). Potassiumchloride (20 mmol) and magnesiumsulphate (1000 mg) is added according to standard protocol.
This arms receives adenosine enriched, intermittent 20:1 diluted warm blood cardioplegic solution.
Intervention: Drug: Adenosine
干预措施: Adenosine (Drug)
结局指标
主要结局
6-hour cardiac Troponin T (cTnT) release
时间窗: 6 hours post-operative
The primary end point is 6-hour cTnT release
次要结局
- Incidence of myocardial injury on 12-lead ECG(participants will be followed for the duration of ICU stay, an expected average of 2 days)
- Vasoactive-inotropic score(participants will be followed for the duration of ICU stay, an expected average of 2 days)
- Incidence of new onset Atrial fibrillation (AF)(participants will be followed for the duration of ICU stay, an expected average of 2 days)
- Mean arterial pressure (MAP)(participants will be followed for the duration of ICU stay, an expected average of 2 days)
- Heart rate (HR)(participants will be followed for the duration of ICU stay, an expected average of 2 days)
- 18-hour cardiac Troponin T (cTnT) area under the curve (AUC) release(cardiac Troponin T (cTnT) AUC will be assessed at different time points, the latest up to 18 hours after ICU arrival)
- Vasoconstrictor usage(participants will be followed for the duration of ICU stay, an expected average of 2 days)
- Routine blood samples(Routine blood samples will be assessed at different time points, the latest up to 6 hours after ICU arrival)
- postoperative left ventricular ejection fraction (LVEF)(postoperative after skin closure, an expected average of 3 hours after starting surgery)
- Wall Motion Score Index (WMSI)(postoperative after skin closure, an expected average of 3 hours after starting surgery)
- Cardiac index (CI)(participants will be followed for the duration of ICU stay, an expected average of 2 days)
- Systemic vascular resistance index (SVRI)(participants will be followed for the duration of ICU stay, an expected average of 2 days)
研究者
Jeffrey Engelhart
PharmD, MSc
Amphia Hospital