Patrick Meybohm1, Berthold Bein, Oana Brosteanu, Jochen Cremer, Matthias Gruenewald, Christian Stoppe, Mark Coburn, Gereon Schaelte, Andreas Böning, Bernd Niemann, Jan Roesner, Frank Kletzin, Ulrich Strouhal, Christian Reyher, Rita Laufenberg-Feldmann, Marion Ferner, Ivo F Brandes, Martin Bauer, Sebastian N Stehr, Andreas Kortgen, Maria Wittmann, Georg Baumgarten, Tanja Meyer-Treschan, Peter Kienbaum, Matthias Heringlake, Julika Schön, Michael Sander, Sascha Treskatsch, Thorsten Smul, Ewa Wolwender, Thomas Schilling, Georg Fuernau, Dirk Hasenclever, Kai Zacharowski. 1. 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.
Abstract
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 intravenouspropofol. 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.).
RCT Entities:
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.).