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

• DOI: 10.2196/preprints.17826
• Publication Date: 2020-01-29T17:42:16Z
• Authors: Jessica Garcia-Su...; Javier Garcia Fer...; Sergio Sanz; Daniel Martinez L...; Leticia Reques; Alberto Forteza Gil
• Keywords: 16. Peace & justice; 3. Good health

<sec> <title>BACKGROUND</title> The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. del Nido solution (DNS) has been widely used preservation for pediatric patients undergoing Its unique pharmacological features have created growing interest adult surgery, especially elderly or those ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies published validate the efficacy, safety, and efficiency DNS in coronary revascularization, valve replacement, combined procedures. Recently, meta-analysis based on nine was claiming noninferiority compared other conventional solutions. Few prospective randomized conducted whose primary outcome assessment clinical efficacy commonly patients. </sec> <title>OBJECTIVE</title> aim this trial assess benefits Cardi-Braun blood biochemical terms regarding surgery. <title>METHODS</title> This protocol controlled, randomized, single-center carried out at Puerta de Hierro Majadahonda University Hospital Spain. A total 474 participants over age 18 years elective bypass will be assigned groups by simple randomization receive either solution. differences between (ie, perioperative troponin levels) presence composite variable &lt;i&gt;acute cardiovascular event&lt;/i&gt;). under conditions respect fundamental rights person ethical principles that affect biomedical research human beings, well accordance international recommendations contained Declaration Helsinki subsequent revisions. <title>RESULTS</title> inclusion process started 2018. Data cleaning analyses expected take place fall 2020 results January 2021. <title>CONCLUSIONS</title> study particularly relevant it one first analyze effects basis direct parameters. In light studies, carrying objectives larger sample, high-risk patients, longer times continues necessary. We believe our addresses an important gap knowledge patient able clarify possible method large population these <title>CLINICALTRIAL</title> 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 <title>INTERNATIONAL REGISTERED REPORT</title> DERR1-10.2196/17826