多中心远程缺血预处理心脏手术试验。
A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery.
机构信息
From the Department of Anesthesiology, Intensive Care Medicine, and Pain Therapy, University Hospital Frankfurt, Frankfurt (P.M., U.S., C.R., K.Z.), the Departments of Anesthesiology and Intensive Care Medicine (P.M., B.B., M.G.) and Cardiovascular Surgery (J.C.), University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Clinical Trial Center (O.B.), the Department of Internal Medicine/Cardiology, University of Leipzig Heart Center (G.F.), and Institute for Medical Informatics, Statistics, and Epidemiology (D.H.), University of Leipzig, Leipzig, the Department of Anesthesiology, University Hospital Aachen, Aachen (C.S., M.C., G.S.), the Department of Cardiovascular Surgery, University of Giessen, Giessen (A.B., B.N.), Clinic of Anesthesiology and Intensive Care Medicine, University Hospital Rostock, Rostock (J.R., F.K.), the Department of Anesthesiology, Medical Center of Johannes Gutenberg University, Mainz (R.L.-F., M.F.), the Department of Anesthesiology and Intensive Care Medicine, University Hospital Göttingen, Göttingen (I.F.B., M.B.), the Department of Anesthesiology and Intensive Care Medicine and Center for Sepsis Control and Care, Jena University Hospital, Jena (S.N.S., A.K.), the Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn, Bonn (M.W., G.B.), the Department of Anesthesiology and Intensive Care Medicine, University Hospital Düsseldorf, Düsseldorf (T.M.-T., P.K.), the Department of Anesthesiology and Intensive Care Medicine, University of Lübeck, Lübeck (M.H., J.S.), the Department of Anesthesiology and Intensive Care Medicine, Charité-Universitätsmedizin Berlin, Campus Charité Mitte, Berlin (M.S., S.T.), the Department of Anesthesiology, University Hospital Würzburg, Würzburg (T. Smul, E.W.), and the Department of Anesthesiology, University Hospital Magdeburg, Magdeburg (T. Schilling) - all in Germany.
出版信息
N Engl J Med. 2015 Oct 8;373(15):1397-407. doi: 10.1056/NEJMoa1413579. Epub 2015 Oct 5.
BACKGROUND
Remote ischemic preconditioning (RIPC) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery, but uncertainty about clinical outcomes remains.
METHODS
We conducted a prospective, double-blind, multicenter, randomized, controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol. The trial compared upper-limb RIPC with a sham intervention. The primary end point was a composite of death, myocardial infarction, stroke, or acute renal failure up to the time of hospital discharge. Secondary end points included the occurrence of any individual component of the primary end point by day 90.
RESULTS
A total of 1403 patients underwent randomization. The full analysis set comprised 1385 patients (692 in the RIPC group and 693 in the sham-RIPC group). There was no significant between-group difference in the rate of the composite primary end point (99 patients [14.3%] in the RIPC group and 101 [14.6%] in the sham-RIPC group, P=0.89) or of any of the individual components: death (9 patients [1.3%] and 4 [0.6%], respectively; P=0.21), myocardial infarction (47 [6.8%] and 63 [9.1%], P=0.12), stroke (14 [2.0%] and 15 [2.2%], P=0.79), and acute renal failure (42 [6.1%] and 35 [5.1%], P=0.45). The results were similar in the per-protocol analysis. No treatment effect was found in any subgroup analysis. No significant differences between the RIPC group and the sham-RIPC group were seen in the level of troponin release, the duration of mechanical ventilation, the length of stay in the intensive care unit or the hospital, new onset of atrial fibrillation, and the incidence of postoperative delirium. No RIPC-related adverse events were observed.
CONCLUSIONS
Upper-limb RIPC performed while patients were under propofol-induced anesthesia did not show a relevant benefit among patients undergoing elective cardiac surgery. (Funded by the German Research Foundation; RIPHeart ClinicalTrials.gov number, NCT01067703.).
背景
有报道称，远程缺血预处理（RIPC）可降低接受体外循环心脏手术患者的缺血再灌注损伤生物标志物水平，但临床结局仍存在不确定性。
方法
我们进行了一项前瞻性、双盲、多中心、随机、对照临床试验，纳入了在全身麻醉下接受择期心脏手术的成年人，麻醉药物为静脉注射异丙酚。该试验比较了上肢 RIPC 与假干预。主要终点是至出院时死亡、心肌梗死、卒中和急性肾衰竭的复合终点。次要终点包括 90 天内任何单一主要终点组成部分的发生情况。
结果
共有 1403 名患者进行了随机分组。全分析集包括 1385 名患者（RIPC 组 692 名，假 RIPC 组 693 名）。RIPC 组和假 RIPC 组复合主要终点的发生率无显著差异（99 例[14.3%] vs. 101 例[14.6%]；P=0.89），各单一组成部分的发生率也无显著差异：死亡（9 例[1.3%] vs. 4 例[0.6%]；P=0.21）、心肌梗死（47 例[6.8%] vs. 63 例[9.1%]；P=0.12）、卒中和急性肾衰竭（14 例[2.0%] vs. 15 例[2.2%]；P=0.79）。意向治疗分析和符合方案集分析的结果也相似。在任何亚组分析中均未发现治疗效果。RIPC 组和假 RIPC 组在肌钙蛋白释放水平、机械通气时间、重症监护病房和医院的住院时间、新发心房颤动以及术后谵妄发生率等方面无显著差异。未观察到与 RIPC 相关的不良事件。
结论
在接受异丙酚诱导麻醉的患者中进行上肢 RIPC 对择期心脏手术患者无明显益处。（由德国研究基金会资助；RIPHeart ClinicalTrials.gov 注册号：NCT01067703）。
Zotero 插件