Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

心脏手术与心肌、神经和肾功能障碍的可预测发生率相关，这些疾病是围手术期发病率和死亡率的重要原因。在许多临床情况下，非重要组织的短暂缺血已被证明可以增强远端器官的耐受性，以科普随后的长期缺血事件，这种现象称为远端缺血预处理。我们假设与无积极干预相比，远程缺血预处理改善了患者术后的结局。我们进行了一项前瞻性、随机、双盲、多中心、对照试验，包括2070例接受心肺转流术的心脏手术患者。患者将被随机分配至远程缺血预处理组，接受4个周期的短暂上肢缺血/再灌注，使用血压袖带充气至高于麻醉诱导后收缩期动脉压15 mm Hg的压力，或随机分配至对照组，接受4个周期的短暂上肢“假”充气/放气至20 mm Hg的压力。主要终点是术后30天内的复合结局（全因死亡率、非致死性心肌梗死、任何新发卒中和/或急性肾衰竭）。次要终点是术后1年内复合终点的任何组成部分、住院时间、心肌损伤、心肌功能（超声心动图）、新发试验性房颤、神经认知功能检查和急性肾损伤。

Cardiac surgery is associated with a predictable incidence of myocardial, neurological and renal dysfunction that account for significant perioperative morbidity and mortality. Transient ischaemia of nonvital tissue has been shown to enhance the tolerance of remote organs to cope with a subsequent prolonged ischaemic event in a number of clinical situations, a phenomenon known as remote ischaemic preconditioning. We hypothesise that remote ischaemic preconditioning improves patient’s outcome after surgery compared to no active intervention. We conduct a prospective, randomised, double-blind, multicentre, controlled trial including 2070 patients undergoing cardiac surgery in which cardiopulmonary bypass is used. Patients will be randomized either to the remote ischaemic preconditioning group receiving four cycles of transient upper limb ischaemia/reperfusion using a blood-pressure cuff inflated to a pressure 15 mm Hg higher than the systolic arterial pressure after induction of anaesthesia, or to the control group receiving four cycles of transient upper limb ‘pseudo’-inflation/deflation to a pressure of 20 mm Hg. Primary endpoint is a composite outcome (all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure) within 30 days after surgery. Secondary endpoints are any component of the composite endpoint within 1 year after surgery, length of hospital stay, myocardial damage, myocardial function (echocardiography), new onset of a trial fibrillation, neurocognitive function test, and acute kidney injury.