Del Nido Cardioplegia Versus Cold Blood Cardioplegia in Adult Cardiac Surgery: Protocol for a Randomized Controlled Trial

被引:5
作者
Garcia-Suarez, Jessica [1 ]
Fernandez, Javier Garcia [1 ]
Sanz, Sergio [1 ]
Lopez, Daniel Martinez [2 ]
Reques, Leticia [2 ]
Gil, Alberto Forteza [2 ]
机构
[1] Puerta de Hierro Majadahonda Univ Hosp, Dept Anesthesiol & Crit Care, C Manuel de Falla 1, Madrid 28222, Spain
[2] Puerta de Hierro Majadahonda Univ Hosp, Dept Cardiovasc Surg, Madrid, Spain
来源
JMIR RESEARCH PROTOCOLS | 2020年 / 9卷 / 07期
关键词
del Nido cardioplegia; cardiac surgery; myocardial protection;
D O I
10.2196/17826
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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.
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页数:7
相关论文
共 12 条
[1]   The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial [J].
Ad, Niv ;
Holmes, Sari D. ;
Massimiano, Paul S. ;
Rongione, Anthony J. ;
Fornaresio, Lisa M. ;
Fitzgerald, David .
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2018, 155 (03) :1011-1018
[2]  
ATAKA K, 1992, CIRCULATION, V86, P371
[3]   del Nido cardioplegia: Passing fad or here to stay? [J].
Lazar, Harold L. .
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2018, 155 (03) :1009-1010
[4]   Del Nido Cardioplegia for Myocardial Protection in Adult Cardiac Surgery: A Systematic Review and Meta-Analysis [J].
Li, Yongnan ;
Lin, Hao ;
Zhao, Yinglu ;
Li, Zhenzhen ;
Liu, Debin ;
Wu, Xiangyang ;
Ji, Bingyang ;
Gao, Bingren .
ASAIO JOURNAL, 2018, 64 (03) :360-367
[5]  
Matte Gregory S, 2012, J Extra Corpor Technol, V44, P98
[6]  
MELROSE DG, 1955, LANCET, V2, P21
[7]   Protecting the aged heart during cardiac surgery: The potential benefits of del Nido cardioplegia [J].
O'Blenes, Stacy B. ;
Friesen, Camille Hancock ;
Ali, Ahmad ;
Howlett, Susan .
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2011, 141 (03) :762-770
[8]   Del Nido cardioplegia in low risk adults undergoing first time coronary artery bypass surgery [J].
Salinas, Gustavo E. Guajardo ;
Nutt, Roger ;
Rodriguez-Araujo, Gerardo .
PERFUSION-UK, 2017, 32 (01) :68-73
[9]   The del Nido versus cold blood cardioplegia in aortic valve replacement: A randomized trial [J].
Sanetra, Krzysztof ;
Gerber, Witold ;
Shrestha, Rajesh ;
Domaradzki, Wojciech ;
Krzych, Lukasz ;
Zembala, Marian ;
Cisowski, Marek .
JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, 2020, 159 (06) :2275-+
[10]   Myocardial Protection Using Del Nido Cardioplegia Solution in Adult Reoperative Aortic Valve Surgery [J].
Sorabella, Robert A. ;
Akashi, Hiro ;
Yerebakan, Halit ;
Najjar, Marc ;
Mannan, Ayesha ;
Williams, Mathew R. ;
Smith, Craig R. ;
George, Isaac .
JOURNAL OF CARDIAC SURGERY, 2014, 29 (04) :445-449