Garcia-Suarez Jessica, Garcia Fernandez Javier, Sanz Sergio, Martinez Lopez Daniel, Reques Leticia, Forteza Gil Alberto
Department of Anesthesiology and Critical Care, Puerta de Hierro Majadahonda University Hospital, Madrid, Spain.
Department of Cardiovascular Surgery, Puerta de Hierro Majadahonda University Hospital, Majadahonda, Madrid, Spain.
JMIR Res Protoc. 2020 Jul 14;9(7):e17826. doi: 10.2196/17826.
The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety, and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement, or combined procedures. Recently, a meta-analysis based on nine retrospective studies was published claiming the noninferiority of DNS compared to other conventional cardioplegia solutions. Few prospective randomized studies have been conducted whose primary outcome was the assessment of DNS clinical efficacy compared to other solutions commonly used in adult patients.
The aim of this randomized clinical trial is to assess the benefits of DNS compared to Cardi-Braun blood cardioplegia solution in clinical and biochemical terms regarding myocardial protection during adult cardiac surgery.
This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Puerta de Hierro Majadahonda University Hospital in Spain. A total of 474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass will be assigned to groups by simple randomization to receive either DNS or Cardi-Braun blood cardioplegia solution. The primary outcome will be the differences between groups in myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable acute cardiovascular event). The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions.
The inclusion process started in 2018. Data cleaning and analyses are expected to take place in the fall of 2020 and the results are expected in January 2021.
This study is particularly relevant as it will be one of the first to analyze the clinical effects of del Nido cardioplegia on the basis of direct myocardial protection parameters. In light of published studies, carrying out prospective studies based on primary clinical objectives with a larger sample, high-risk patients, and longer cardiopulmonary bypass times continues to be necessary. We believe that our study addresses an important gap in the knowledge of del Nido cardioplegia in adult patient cardiac surgery and will be able to clarify the possible benefits of this method in a large population of patients undergoing these procedures.
European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2017-005144-14; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+; ClinicalTrials.gov NCT04094168; https://clinicaltrials.gov/ct2/show/NCT04094168.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17826.
在体外循环心脏手术中，使用心脏停搏液作为心肌保护技术至关重要。德尔尼多心脏停搏液（DNS）已被广泛用作接受体外循环心脏手术的儿科患者的心肌保护技术。其独特的药理学特性引起了成人心脏手术领域越来越多的关注，特别是对于老年患者或那些更易发生缺血再灌注损伤的心室功能不全患者。自其应用以来，已发表了多项回顾性研究，以验证DNS在接受冠状动脉血运重建、瓣膜置换或联合手术的成年患者中的疗效、安全性和有效性。最近，一项基于9项回顾性研究的荟萃分析发表，声称DNS与其他传统心脏停搏液相比具有非劣效性。很少有前瞻性随机研究以评估DNS与成年患者常用的其他溶液相比的临床疗效作为主要结果。
本随机临床试验的目的是在成人心脏手术期间，从临床和生化方面评估DNS与Cardi-Braun血液心脏停搏液相比在心肌保护方面的益处。
这是在西班牙普埃尔塔德耶罗马亚达洪达大学医院进行的一项对照、随机、单中心临床试验方案。共有474名年龄超过18岁、接受择期体外循环心脏手术的参与者将通过简单随机分组被分配到接受DNS或Cardi-Braun血液心脏停搏液的组中。主要结果将是两组在生化方面（即围手术期肌钙蛋白水平）和临床方面（即复合变量急性心血管事件的存在）心肌保护的差异。该临床试验将在尊重人的基本权利和影响人类生物医学研究的伦理原则的条件下进行，并符合《赫尔辛基宣言》及其后续修订版中的国际建议。
纳入过程于2018年开始。数据清理和分析预计在2020年秋季进行，结果预计在2021年1月得出。
本研究特别重要，因为它将是首批基于直接心肌保护参数分析德尔尼多心脏停搏液临床效果的研究之一。根据已发表的研究，继续有必要开展基于主要临床目标且样本量更大、针对高危患者以及体外循环时间更长的前瞻性研究。我们相信，我们的研究填补了成人患者心脏手术中德尔尼多心脏停搏液知识方面的重要空白，并将能够阐明该方法在大量接受这些手术的患者中可能带来的益处。
欧盟药品监管当局临床试验数据库（EudraCT）2017 - 005144 - 14；https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+；ClinicalTrials.gov NCT04094168；https://clinicaltrials.gov/ct2/show/NCT04094168。
国际注册报告识别码（IRRID）：DERR1-10.2196/17826。
