Comparison of Lactated Ringer's Solution and PlasmaLyte-A as a Base Solution for Del Nido Cardioplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Myocardial injury
研究概览
简要总结
Del Nido cardioplegia has been used exclusively for myocardial protection in pediatrics cardiac surgery for decades. Its unique properties including lidocaine which helps counteract potassium depolarization of the myocardial cell membrane, inhibition of intracellular calcium accumulation, preservation of intracellular high-energy phosphates, free-radical scavenging and acid-base buffering have been proven to be very effective for myocardial protection during cardiac surgery for congenital heart disease and acquired heart disease. Recent studies have proven its safety, efficacy, and cost-effectiveness for myocardial protection in adult cardiac surgery as a single dose cardioplegia which is typically administered in a single dose fashion or with extended dosing intervals. In contrast, Traditional blood cardioplegia is commonly administered approximately every 20 minutes. These characteristics of del Nido cardioplegia allow for fewer interruptions and improve surgical workflow. The base solution for del Nido cardioplegia is normally Plasma-Lyte A (Baxter Healthcare Corporation, Deerfield, IL, USA) which has an electrolyte composition similar to the extracellular fluid and is calcium-free. Unfortunately, an unavailability of PlasmaLyte-A in many countries precluding utilization of del Nido cardioplegia with its normal base solution in many cardiac centers. To access the benefits of del Nido cardioplegia, we utilize lactated Ringer's solution as the base solution. This prospective randomized study aimed to evaluate myocardial preservation and clinical outcomes when using lactated Ringer's solution compared with PlasmaLyte-A as a base solution for del Nido cardioplegia.
详细描述
This clinical trial is performed at Ramathibodi hospital, Mahidol university in Bangkok, Thailand. The protocol has been approved by institutional ethical committee (ref. ID 03-61-43) with informed consent required for all patients.
The difference of 24 hour post-op troponin level between the del Nido cardioplegia and the blood cardioplegia group from previous randomized study were 2.3 (SD 2.1) and 7.0 (SD 14.7) ng/mL, respectively (p = 0.053). Our previous observational study also exhibited comparable results between modified del Nido cardioplegia and blood cardioplegia. The author estimated the sample size of 160 randomized patients to give 80% power at the 5% significant level (alpha 0.05, beta 0.2). Giving allowance for attrition, a sample size of 100 was chosen in each group.
Patients aged 18 years or older undergoing elective cardiac surgery for acquired heart disease (including isolated coronary artery bypass grafting(CABG), isolated valve surgery, combined valve surgery, or concomitant CABG and valve surgery) are randomized 1:1 into lactated Ringer's solution (study group) and PlasmaLyte-A (control group).
For patients randomized to lactated Ringer's solution (study group), lactated Ringer's solution is used as a base solution for del Nido cardioplegia.
For patients randomized to PlasmaLyte-A (control group), PlasmaLyte-A (Baxter Healthcare Corporation, Deerfield, IL, USA) is used as a base solution for del Nido cardioplegia.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 years or older undergoing elective adult cardiac surgery
排除标准
- •Emergency surgery
- •Patient who does not want to participate in the study
- •Lidocaine allergy
研究组 & 干预措施
Lactated Ringer's solution
For patients randomized to lactated Ringer's solution (study group), lactated Ringer's solution is used as a base solution for del Nido cardioplegia.
干预措施: Lactated Ringer (Drug)
PlasmaLyte-A
For patients randomized to PlasmaLyte-A (control group), PlasmaLyte-A (Baxter Healthcare Corporation, Deerfield, IL, USA) is used as a base solution for del Nido cardioplegia.
干预措施: Lactated Ringer (Drug)
结局指标
主要结局
Myocardial injury
时间窗: 24 hour post-op
troponin-T level at 24 hour post-op
次要结局
- Incidence of intra-aortic balloon pump (IABP) insertion(up to 1 hour (During admission in intensive care unit))
- Incidence of ventricular fibrillation after aortic cross-clamp removal(Intra-operative period)
- Post-op left ventricular ejection fraction (LVEF) change(Intra-operative period)
- Duration of inotrope/vasopressor requirement(up to 1 hour (During admission in intensive care unit))
- Incidence of Operative mortality(up to 1 month postoperatively)
- Incidence of Permanent Stroke(up to 1 month postoperatively)
- Incidence of Renal Failure(up to 1 month postoperatively)
- Incidence of Prolonged Ventilation > 24 hours(up to 1 month postoperatively)
- Incidence of Deep sternal wound infection(up to 1 month postoperatively)
- Incidence of Reoperation for any reason(up to 1 month postoperatively)
- Incidence of Major Morbidity or Operative Mortality(up to 1 month postoperatively)