Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial

This 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 outcom e 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 und...
Source: Trials - Category: Research Source Type: clinical trials