Modified Del Nido Versus Custodiol Cardioplegia For Myocardial Protection In Adult Patients Undergoing Cardiac Surgery; A Prospective Randomized Double-Blinded Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- troponin I
研究概览
简要总结
Cardioplegia solutions have been considered as a corner stone for myocardial protection during cardiac surgery with cardiopulmonary bypass and cardiac arrest, it limits the metabolic activity and increases the capacity of the myocardium to withstand prolonged ischemic time, and thus it has a direct impact on surgical outcomes. (1, 2) Long acting cardioplegic solutions with a single dose strategy are beneficial as they allow surgery without interruptions, reducing cross clamp time and provide more cardiac protection. (3) Custodiol (histidine- tryptophan- ketoglutarate) solution has been described in the 1970s by Bretschneider (4), and used as an alternative to hyperkalemic crystalloid solutions especially during complex cardiac surgeries, also used for organ preservation during transplant surgery. (5, 6) In the 1990s Pedro del Nido and his team introduced a new cardioplegic solution (del Nido cardioplegia) for pediatric cardiac surgeries. (7) But recently, many studies postulated its use for adults. (8) The base solution for the traditional del Nido cardioplegia is Plasma-Lyte A which is a calcium free solution and electrolyte composition similar to the extracellular fluid. (7) However Plasma-Lyte A is unavailable in many countries, this precludes its use. Some authors have advocated lactated Ringer's as a base solution instead of Plasma-Lyte A for preparing del Nido cardioplegia, now known as modified del Nido cardioplegia. (9) Custodiol and modified del Nido cardioplegia can be used in a single dose fashion with proper myocardial protection and minimal surgical interruptions. However, the literature also does not confirm the superiority of one over another. (1) Also, limited number of clinical trials compared both cardioplegic solutions directly. So, in this study we aimed to assess the efficacy of both Custodiol and modified del Nido cardioplegia in myocardial protection and clinical outcomes among adult patients undergoing cardiac surgery.
详细描述
Patients will be divided into two groups with 1:1 allocation, randomized by computer generated random numbers that will be placed in separate opaque envelopes opened by study investigators at OR. MDN group (will receive modified Del Nido cardioplegia solution) and C group (will receive Custodiol cardioplegia). Participants and data collectors will be blinded with the group allocation till the end of the study.
Inclusion criteria: patients ≥ 18 years old, scheduled for elective valve replacement surgery or coronary artery bypass grafting surgery.
All patients will be preoperatively examined and investigated by complete blood count, coagulation profile, liver and kidney functions and electrolytes. Electrocardiography, chest x ray and echocardiography will be routinely done. Coronary angiography and carotid arterial duplex will be requested on demand.
Patient will be premedicated by intramuscular injection of 10mg morphine at morning of the operation. Before induction of anesthesia, a five-lead electrocardiography system will be applied to monitor heart rate, rhythm, and ST segments (leads II and V5). A pulse oximeter probe will be attached, and a peripheral venous cannula will be placed. For measurement of arterial pressure and blood sampling, a 20 G cannula will be inserted into either right or left radial artery under local anesthesia. After pre-oxygenation, general anesthesia will be induced by midazolam 2-5 mg, fentanyl (10μg/kg), propofol (3-4mg/Kg), followed by atracurium (0.5 mg/kg).
Trachea will be intubated; patients will be mechanically ventilated with oxygen in air so as to achieve normocarbia. This will be confirmed by radial arterial blood gas analysis and capnogram. An esophageal temperature probe and a urinary catheter will also be placed. For drug infusion, a triple-lumen central venous catheter will be inserted via the right internal jugular vein. Anesthesia will be maintained by inhaled Isoflurane 0.4 to 1% and atracurium infusion at a rate of 0.5 mg/kg/h for continued muscle relaxation. During extracorporeal circulation, patients will receive propofol infusion at a rate of 50-100 µ/kg/min. in addition to atracurium infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 是
入选标准
- •patients ≥ 18 years old, scheduled for elective valve replacement surgery or coronary artery bypass grafting surgery.
排除标准
- •Emergency surgery.
- •Chronic kidney disease.
- •Hepatic impairment.
- •Re-do surgery.
- •Severe psychiatric illness.
研究组 & 干预措施
MDN group
will receive modified Del Nido cardioplegia solution
干预措施: Modified Del Nido Versus Custodiol Cardioplegia (Drug)
C group
will receive Custodiol cardioplegia
干预措施: Modified Del Nido Versus Custodiol Cardioplegia (Drug)
结局指标
主要结局
troponin I
时间窗: 24 hours after surgery
troponin I at 24 hours after surgery to assess myocardial protection between the two used cardioplegia solutions.
次要结局
- Total cross-clamp time and total CPB time(In the first 24 hours of surgery)
- Postoperative left ventricular ejection fraction(24 hours after surgery in days)
- Requirement of inotropes and time of discontinuation(postoperative 24 hours)
- ICU length of stay(24 hours after surgery in days)
- The total volume of cardioplegia solution(In the first 24 hours of surgery)
- Serum lactate level at 24 hours after surgery.(24 hours after surgery)
- Incidence of postoperative AF and MI.(24 hours after surgery)
- CK-MB at 12 and 24 hours after surgery(24 hours after surgery)
- Time for weaning from mechanical ventilation(24 hours after surgery in hours)
- Incidence of ventricular fibrillation after cross-camp removal(In the first 24 hours of surgery)
- Troponin I at 12 hours after surgery(postoperative 24 hours)
- hospital length of stay(24 hours after surgery in days)
研究者
Mahdy Ahmed Abd Elhady
Fayoum University Hospital
Fayoum University Hospital