Randomized and open clinical trial to compare the efficacy and safety of Buckberg versus Del Nido cardioplegia in isolated myocardial revascularization surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Markers of myocardial damage: Peak levels of CK in U/L and ultrasensitive Troponin T in ng/L in blood. Basal levels will be determined daily during the first 5 postoperative days. The peak of CK and Troponin T will be recorded for each of the study subjects (usually it occurs during postoperative days 2 and 4).
研究概览
简要总结
The main objective of the study is to study the efficacy and safety in terms of myocardial protection in patients undergoing isolated myocardial revascularization surgery with extracorporeal circulation of two cardioplegic solutions: Del Nido cardioplegia versus Buckberg cardioplegia. For this purpose, levels of myocardial injury markers (CK and Troponin T) and in-hospital mortality will be compared between both strategies.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients of legal age (>18 years) of both sexes.
- •Patients undergoing isolated myocardial revascularization surgery with extracorporeal circulation.
- •Patients providing the informed consent.
排除标准
- •Emergent surgery
- •Acute coronary syndrome with or without ST elevation in the last 48 hours.
- •Patient who rejects blood products
- •Patients with concomitant medical conditions that determine the need to use one or another cardioplegic solution; such as advanced chronic kidney disease, diabetes with poor glycemic control or significant preoperative anemia that requires hemodilution to be reduced as much as possible.
结局指标
主要结局
Markers of myocardial damage: Peak levels of CK in U/L and ultrasensitive Troponin T in ng/L in blood. Basal levels will be determined daily during the first 5 postoperative days. The peak of CK and Troponin T will be recorded for each of the study subjects (usually it occurs during postoperative days 2 and 4).
Markers of myocardial damage: Peak levels of CK in U/L and ultrasensitive Troponin T in ng/L in blood. Basal levels will be determined daily during the first 5 postoperative days. The peak of CK and Troponin T will be recorded for each of the study subjects (usually it occurs during postoperative days 2 and 4).
Operative mortality. Operative mortality will be considered mortality in the following 30 days after the surgical intervention, or mortality during admission for the intervention (in patients whose admission exceeds 30 postoperative days).
Operative mortality. Operative mortality will be considered mortality in the following 30 days after the surgical intervention, or mortality during admission for the intervention (in patients whose admission exceeds 30 postoperative days).
次要结局
- Aortic clamping time (minutes)
- Extracorporeal circulation time (minutes)
- Spontaneous recovery of the rhythm after aortic unclamping: it will be recorded during the intraoperative period if there is spontaneous recovery of the cardiac rhythm after removing the aortic clamp.
- Need for post-aortic unclamping defibrillation: it will be recorded if defibrillation is necessary to recover one's own heart rhythm.
- Need for inotropes for weaning from CPB: it will be recorded if the administration of inotropes is necessary for weaning from CPB. If yes, the type and maximum dose of inotrope required will be recorded.
- Maximum intraoperative blood glucose (in mmol/L).
- Intraoperative insulin needs and during the 48 hours postoperatively.
- Minimum intraoperative, postoperative and discharge hemoglobin (in g/L).
- Maximum intraoperative lactate (in mmol/L),
- Need for intraoperative and postoperative red blood cell transfusion.
- Inotrope need and duration during intra- and postoperative.
- Need for mechanical circulatory assistance: need for circulatory support using a counterpulsation balloon or ECMO.
- Perioperative myocardial infarction according to the 5th universal definition.
- Episodes of de novo atrial fibrillation.
- Intubation hours.
- Left ventricular function by echocardiography at discharge.
- Cardiac resonance (subgroup of patients): one pre-surgery and another 7-10 days after surgery with cine sequences, mapping and late enhancement.
- Days of admission to the ICU.
- Total hospitalization days.
研究者
Manel Tauron Ferrer
Scientific
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau