Multimodal cardio protective strategy in cardiac surgery (The PROCCARD trial): Study protocol for a multicenter randomized controlled trial

Abstract

Background Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Different protective strategies dealing either with preconditioning or postconditioning or assessing a single aspect of cardioprotection showed conflicting results. We tested the hypothesis that a multimodal approach would improve cardioprotection and limit myocardial damage following cardiac surgery with cardiopulmonary bypass. Methods This study is a pragmatic multicenter (six French institutions), prospective, randomized, single-blinded, controlled trial. The randomization is stratified by centers. 210 patients scheduled for aortic valve surgery with or without coronary artery bypass grafting will be assigned to a control or a treated 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 treated 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 the myocardial damage measured by postoperative 72-h area under the curve of high-sensitive cardiac troponin I. Discussion The ProCCard study will be the first multicenter randomized controlled trial aiming to assess the role of a bundle of care combining several cardio protective strategies to reduce myocardial damage in patients undergoing cardiac surgery with cardiopulmonary bypass.