A Prospective Randomized Double Blind Multicenter Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery Custodiol-N Versus Custodiol
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- CK-MB area under the curve within 24 hours
研究概览
简要总结
Comparison of the cardioprotective effects and safety of two cardioplegic solutions (solutions used during a cardiac arrest in the heart surgery) in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery.
详细描述
The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate non-inferiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB area under the curve (primary endpoint), catecholamine requirement(cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study population will be selected from patients of either sex with coronary artery disease (CAD) who are to undergo cardiopulmonary bypass for coronary artery bypass surgery.
- •Patients >/=35 and </=80 years of age
- •Male or female with 2 or 3 vessel coronary disease, who are scheduled for elective CBP surgery for coronary revascularisation
- •Presence of definite CAD for which surgical intervention is deemed necessary, without evidence of ongoing infarction.
- •Patients with unstable angina can be included as long as there is no objective (negative cardiac isoenzymes in the immediate six hours preceding CABG, current intravenous use of nitrate therapy) or subjective (absence of prolonged symptoms suggestive of coronary insufficiency that do not respond to pharmacologic intervention) evidence of myocardial necrosis.
- •Eligibility for Swan-Ganz-Catheter
- •Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
- •No evidence of severe organic or psychiatric disease by history or physical examination
- •No history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or no any history of drug abuse or addiction within 12 months of study enrollment.
排除标准
- •Patients undergoing valve repair or replacement
- •History of recent (< 6 weeks) Q-wave myocardial infarction
- •Left ventricular ejection fraction < 35% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning [MUGA], or 2-D ECHO)
- •Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery
- •Pregnant or lactating patients
- •Patients who have participated in any other investigational studies within 30 days previous to enrollment
- •Patients in cardiogenic shock (defined as a systolic BP < 90 mmHg for over one hour despite inotropic and chronotropic support)
- •Patients with severe chronic obstructive lung disease (FEV1 < 50%)
- •Previous cardiac valvular disease (clinical relevant)
- •Dialysis or creatinine > 2 mmol/L
- •BMS-Stent < 4 weeks
- •DES-Stent < 6 month
- •Guidance depended Plavix therapy
研究组 & 干预措施
Custodiol
After cross clamping of the aorta on cardiopulmonary bypass, the Custodiol solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.
干预措施: Custodiol (Drug)
Custodiol-N
After cross clamping of the aorta on cardiopulmonary bypass, the Custodiol-N solution, at a temperature of 4 - 6°C, will be infused antegrade into the root of the aorta.
干预措施: Custodiol-N (Drug)
结局指标
主要结局
CK-MB area under the curve within 24 hours
时间窗: Up to 24 hours after the aortic clamp release
Measurements will be carried out at the following timepoints: 4,8,12,16,20,24 hours (± 30 min) after release of the aortic cross clamp
次要结局
- Catecholamine requirement(24 hours (cumulative dose))
- CK-MB peak(Up to day 5)
- Mortality any time during post-op through Day 30(Up to Day 30)