A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery
| Autor: | Matthias Gruenewald, Mark Coburn, Jochen Cremer, Christian Reyher, Julika Schön, Bernd Niemann, Peter Kienbaum, Rita Laufenberg-Feldmann, Andreas Böning, Matthias Heringlake, Marion Ferner, Michael Sander, Martin Bauer, U. Strouhal, Andreas Kortgen, Oana Brosteanu, Thorsten Smul, Sascha Treskatsch, Tanja Meyer-Treschan, Christian Stoppe, Thomas F. Schilling, Sebastian Stehr, I. F. Brandes, Georg Fuernau, Maria Wittmann, Kai Zacharowski, Berthold Bein, Jan P. Roesner, G. Schaelte, Ewa Wolwender, Patrick Meybohm, Georg Baumgarten, Dirk Hasenclever, Frank Kletzin |
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| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Kaplan-Meier Estimate law.invention Upper Extremity Postoperative Complications Randomized controlled trial Double-Blind Method law Ischemia Multicenter trial medicine Cardiopulmonary bypass Clinical endpoint Humans Myocardial infarction Prospective Studies Treatment Failure Cardiac Surgical Procedures Ischemic Preconditioning Stroke Propofol Aged Cardiopulmonary Bypass business.industry Sham Intervention General Medicine Length of Stay Middle Aged medicine.disease Heart Surgery Troponin 3. Good health Surgery Cardiac surgery Elective Surgical Procedures Anesthesia Anesthesia Intravenous Female business |
| Popis: | 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.). peerReviewed |
| Databáze: | OpenAIRE |
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