Abstract
BackgroundMyocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Different protective strategies dealing with either preconditioning or postconditioning or assessing a single aspect of cardioprotection have shown conflicting results. We tested the hypothesis that a multimodal approach would improve cardioprotection and limit myocardial damage following cardiac surgery with cardiopulmonary bypass.MethodsThis study is a pragmatic multicenter (six French institutions), prospective, randomized, single-blinded, controlled trial. The randomization is stratified by centers. In the study, 210 patients scheduled for aortic valve surgery with or without coronary artery bypass grafting will be assigned to a control or a treatment group (105 patients in each group). In the control group, patients receive total intravenous anesthesia with propofol and liberal intraoperative blood glucose management (initiation of insulin infusion when blood glucose, measured every 60 min, is greater than 180 mg/dl), as a standard of care. The treatment group receives a bundle of care combining five techniques of cardioprotection: (1) remote ischemic preconditioning applied before aortic cross-clamping; (2) maintenance of anesthesia with sevoflurane; (3) tight intraoperative blood glucose management (initiation of insulin infusion when blood glucose, measured every 30 min, is greater than 140 mg/dl); (4) moderate respiratory acidosis (pH 7.30) at the end of cardiopulmonary bypass; and (5) a gentle reperfusion protocol following aortic unclamping. The primary outcome is myocardial damage measured by postoperative 72-h area under the curve of high-sensitivity cardiac troponin I.DiscussionThe ProCCard study will be the first multicenter randomized controlled trial aiming to assess the role of a bundle of care combining several cardioprotective strategies to reduce myocardial damage in patients undergoing cardiac surgery with cardiopulmonary bypass.Trial registrationClinicalTrials.gov, NCT03230136. Registered on July 26, 2017. Last updated on April 17, 2019.
Highlights
Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality
Cardiac surgery with cardiopulmonary bypass (CPB) induces, consecutive to aortic clamping–unclamping, myocardial damage related to ischemia-reperfusion
Similar interventions applied at the onset of reperfusion, a process named postconditioning by analogy with preconditioning, have been described [4]
Summary
Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Cardiac surgery with cardiopulmonary bypass (CPB) induces, consecutive to aortic clamping–unclamping, myocardial damage related to ischemia-reperfusion. Similar interventions applied at the onset of reperfusion, a process named postconditioning by analogy with preconditioning, have been described [4]. Since these first publications, a very large number of experimental studies have been carried out to characterize these phenomena and to understand their mechanisms. Most studies have been done in patients undergoing CPB These specific clinical conditions, such as the major inflammatory processes induced by the heart–lung machine, the influence of the anesthetic agents, or the specificity of each cardiac surgical procedure, may complicate the interpretation of the results of such studies. The biological effect of a single cardioprotective procedure might not be strong enough for translation into heterogeneous routine clinical situations, to standardized experimental models
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