The Use of Del Nido Cardioplegia in Adult Cardiac Surgery: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 99
- 试验地点
- 4
- 主要终点
- Defibrillation requirement
研究概览
简要总结
The use of a modified depolarizing cardioplegia solution in adult cardiac surgery would allow for prolonged re-dosing intervals while providing equivalent myocardial protection. The use of del Nido solution has been used extensively in congenital heart surgery for over 25 years. The primary objective is to determine whether expanding this technique to adult cardiac surgery will confer significant benefits in both surgical workflow and patient clinical outcome. The investigators hypotheses with regard to the del Nido solution will demonstrate (1) a non-inferior delivery to the current blood-based cardioplegia strategy in functional recovery or clinical outcome, and (2) superior delivery to the current blood-based cardioplegia strategy in cost analyses.
详细描述
This prospective randomized controlled trial is designed for adult patients between the ages of 19-79 presenting for isolated CABG or single valve surgery, with or without CABG, requiring the use of Cardio-Pulmonary Bypass (CPB). Patients with previous cardiac surgery or requiring mechanical and pharmacologic support will be excluded from the study.
Subjects randomized to the intervention group will receive del Nido cardioplegia solution during the aortic cross clamp period. The control group will receive whole-blood cardioplegia according to the Inova Fairfax Adult Cardioplegia protocol. Primary outcomes include clinical indicators for myocardial preservation such as serum troponin levels and the return of spontaneous rhythm. Surrogate primary endpoints for myocardial protection include the requirement for inotropic support and the need for defibrillation after coronary reperfusion. Secondary endpoints include post-operative clinical outcomes, duration of the aortic cross clamp period, and total expenses incurred during the patient length of stay.
The investigators will conduct non-inferiority analyses to examine the effect of cardioplegia treatment arm on clinical outcomes and complications. Analyses of binary outcomes will use a 5% non-inferiority margin and analyses of continuous outcomes will use a 10% non-inferiority margin.
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
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects able to receive and provide informed consent
- •Elective surgical procedures requiring CPB and myocardial arrest
- •Isolated coronary artery bypass graft (CABG) surgery or single valve surgery, with or without CABG
排除标准
- •Previous cardiac surgery
- •Patients with preoperative inotropic pharmacological support
- •Patients on preoperative mechanical circulatory support
- •Patients with an implanted pacemaker or implantable cardioverter defibrillator
- •Patients with non-isolated CABG or other non-CABG procedures with single valve surgery
结局指标
主要结局
Defibrillation requirement
时间窗: Collected from beginning of surgery until discharge from the hospital, an expected average of 9 days.
• Defibrillation requirement will be measured as: * Defibrillation needed after coronary reperfusion (Y/N) * Number of defibrillations required
Return to spontaneous sinus rhythm
时间窗: Collected from beginning of surgery until transfer of patient out of the operating room.
Return to spontaneous sinus rhythm measured as yes or no
Change in blood troponin levels
时间窗: Measured once immediately before surgery, then at 3 time-points post surgery (at 2, 12, 24 hours post-surgery).
• Blood troponin levels measured at: * Baseline prior to surgery * 2 hours after termination of cardiopulmonary bypass * 12 hours after admission to the Cardiac Intensive Care Unit * 24 hours after admission to the Cardiac Intensive Care Unit
Inotropic requirement
时间窗: Assessed from beginning of surgery until patient is discharged from the hospital, an expected average of 9 days.
• Inotropic requirements will be measures as: * Inotropic pharmacologic support (Y/N) * Duration of inotropic support after cardiopulmonary bypass measured in hours
Hemodynamic instability
时间窗: Collected from beginning of surgery until discharge from the hospital, an expected average of 9 days.
Measures as return to cardiopulmonary bypass (CPB) due to hemodynamic instability (Y/N)
次要结局
- Ejection fraction at termination of CPB(During surgical procedure at the termination of CPB)
- Total aortic cross clamp duration(Measured during surgery from start to end of aortic cross clamp)
- Total duration of CPB(Measured during surgery from start to end of CPB)
- Amount of cardioplegia solution(Measured from start to end of surgery)
- Total expense of surgical stay(Measured from patient admission to hospital until discharge from hospital, an expected average of 9 days.)
- Post-Operative Clinical Outcomes(Assessed from beginning of surgery until patient discharge from hospital, an expected average of 9 days, or up to 30 days after surgery for select outcomes (see below).)
- Cardioplegia costs(Measured from start to end of surgery)