Comparison of Low Sodium Crystalloid Bretschneider-HTK Cardioplegia With Del Nido Cardioplegia in Patients Undergoing Elective Aortic Valve Replacement - a Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- postoperative CK-MB
研究概览
简要总结
The goal of this clinical trial is to compare del Nido and Bretschneider-HTK (HTK) cardioplegia solutions in patients undergoing elective aortic valve replacement. The main question it aims to answer is:
• Does the del Nido cardioplegia provide better cardioprotection and clinical outcomes than HTK cardioplegia? Participants will receive one of the investigated cardioplegia solutions according to the randomization.
Researchers will compare both groups in terms of cardioprotection (described as levels of CK-MB and hsTnI), in-hospital clinical outcomes, biochemical changes in coronary sinus blood and one-year follow-up.
详细描述
The idea of using del Nido cardioplegia in adult cardiac surgery appeared after many reports proving its safety and efficacy in the paediatric population. Therefore many adult centres started to apply it in everyday practice. Despite its growing popularity and application in different types of cardiac surgeries, there is still an insufficient number of prospective randomized trials which compare del Nido cardioplegia with the Bretschneider-HTK formula in the adult population.
The described problem will be analyzed at different levels in this prospective, randomised study.
Clinical aspects - del Nido and HTK cardioplegia will be compared in terms of intraoperative and postoperative details such as perfusion details and concentration of cardiac enzymes.
Echocardiographic changes - The next step will be revealing potential echocardiographic changes in cardiac function in short- and long-term observations after cardiac surgery.
Metabolic changes - the metabolic profile of amino acids and nucleotide changes after each cardioplegia solution delivery will be analyzed.
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
- Single (Participant)
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 aged 18 and over,
- •qualified for elective isolated aortic valve replacement (AVR)
排除标准
- •patients with significant coronary artery disease,
- •urgent cases,
- •cases with additional cardiac procedures.
研究组 & 干预措施
del Nido cardioplegia group
A group of patients that received high potassium cardioplegic solution with the addition of lidocaine, mixed with the patient's blood in 4:1 ratio
干预措施: Del Nido Cardioplegia Solution (Drug)
Bretschneider-HTK cardioplegia group
A group of patients that received low sodium cardioplegic solution with the addition of histidine, tryptophan and alpha-ketoglutarate
干预措施: HTK solution (Drug)
结局指标
主要结局
postoperative CK-MB
时间窗: measured in the 6th, 24th, and 48th hour postoperatively
concentration of serum creatine kinase-myocardial band (CK-MB)
postoperative hsTnI
时间窗: measured in the 6th, 24th, and 48th hour postoperatively
concentration of serum high sensitive cardiac troponin I (hsTnI)
次要结局
- Reperfusion time(intraoperative)
- Cardioplegia volume(intraoperative)
- CPB time(intraoperative)
- XC time(intraoperative)
- Cardioplegia doses(intraoperative)
- Heart rhythm after XC(intraoperative)
- Need for defibrillation(intraoperative)
- Number of defibrillations(intraoperative)
- Intraoperative lactate concentration(intraoperative)
- Intraoperative pH results(intraoperative)
- Intraoperative partial pressure of oxygen(intraoperative)
- Intraoperative partial pressure of carbon dioxide(intraoperative)
- Intraoperative base deficit(intraoperative)
- Intraoperative sodium and potassium concentration(intraoperative)
- Intraoperative amino acids concentrations(intraoperative)
- Intraoperative nucleotides concentrations(intraoperative)
- Ventilation time(30 postoperative days)
- ICU length of stay(30 postoperative days)
- Hospital length of stay(30 postoperative days)
- Postoperative lactate concentration(30 postoperative days)
- Postoperative pH results(30 postoperative days)
- Postoperative partial pressure of oxygen(30 postoperative days)
- Postoperative partial pressure of carbon dioxide(30 postoperative days)
- Postoperative base deficit(30 postoperative days)
- Postoperative sodium and potassium levels(30 postoperative days)
- Maximum CRP concentration(30 postoperative days)
- Discharge CRP concentration(30 postoperative days)
- Maximum creatinine concentration(30 postoperative days)
- Discharge creatinine concentration(30 postoperative days)
- Discharge Hb concentration(30 postoperative days)
- Discharge Hct concentration(30 postoperative days)
- Discharge WBC concentration(30 postoperative days)
- VIS(30 postoperative days)
- Rate of postoperative transfusions(30 postoperative days)
- Rate of resternotomy(30 postoperative days)
- Rate of pericardial drainage(30 postoperative days)
- Rate of stroke(30 postoperative days)
- Rate of myocardial infarction(30 postoperative days)
- Rate of new-onset arrhythmias(30 postoperative days)
- In-hospital mortality rate(30 postoperative days)
- Out-hospital mortality rate(approx one year postoperatively)
- Rate of pacemaker implantation(approx one year postoperatively)
- Rate of secondary hospitalization(approx one year postoperatively)
- LVEF values changes(approx one year postoperatively)
- Diastolic function changes(approx one year postoperatively)
- 2STE parameter changes(approx one year postoperatively)
研究者
Barbara Brzeska MD
Principal Investigator
Medical University of Gdansk