6%基乙烯粉在接受重大手术的患者的安全性和有效性:随机对照PHOENICS试验
Wolfgang Buhre1, Óscar Díaz-Cambronero, Simon Schaefer
1From the Department of Anaesthesiology, Division of Vital Functions, University Medical Centre Utrecht Q4.2.300, Utrecht, The Netherlands (WB), Department Anesthesiology, Hospital Universitario y Politécnico la Fe Perioperative Medicine Research, Health Research Institute Hospital la Fe, Valencia, Spain, Faculty of Medicine, Department of Surgery, University of Valencia, Spain (ÓD-C), LMU Klinikum, Ludwig Maximilians-University München, München, Universitätsmedizin Oldenburg, Universitätsklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Carl von Ossietzky Universität Oldenburg und Klinikum Oldenburg, Oldenburg, Germany (SS), Department of Anaesthesia and Intensive Care, Oblastni nemocnice Kolin, a.s, Czech Republic (MN), Department of Anesthesiology and Intensive Care, Hospital IMED Valencia, Valencia, Spain (MSD), Jessa Hospital, Hasselt University, Hasselt, Belgium (BS), Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas, Spain (AR-P), Department of Anaesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Dresden (TR), Universitätsmedizin Oldenburg, Universitätsklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie, Carl von Ossietzky Universität Oldenburg und Klinikum Oldenburg, Oldenburg, Germany (GR), Department of Anaesthesiology and Intensive Care, Hôpital Européen Georges Pompidou, AP-HP, Paris, Université Paris Cité, INSERM UMR-S1140 "Innovations Thérapeutiques en Hémostase", Paris, France (BC), University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (MG), Maastricht University Medical Center+, Maastricht, the Netherlands (GK), Service d'Anesthésie-Réanimation Saint Eloi, Centre Hospitalier Universitaire de Montpellier, Université, Montpellier, France (SJ), Maastricht University Medical Center+, Maastricht, the Netherlands (DdK), University of Valencia, Valencia, Spain (JB), Department of Anaesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Dresden, Germany, Department of Intensive Care and Resuscitation, Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio, USA (MGdA), University Hospital Centre Zagreb, Zagreb, Croatia (RB), Department of Anaesthesiology and Intensive Care Medicine, Münster University Hospital, Münster, Germany (TS), Anesthesiology Department, Hospital Clínic de Barcelona, Barcelona, Spain (CFO), Centre for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Anesthesia and Intensive Care Department, 5th Military Hospital, Krakow, Poland (WS), Department of Anaesthesia and Intensive Care, Fundeni Clinical Institute, Bucharest, Romania (DT), University Hospital Motol, Prague, Czech Republic (TV), University Hospital Center Sestre Milosrdnice, Zagreb, Croatia (ZG), Department of Anesthesiology, Hospital Universitario y Politécnico la Fe, Perioperative Medicine Research, Health Research Institute Hospital la Fe, Faculty of Medicine, Department of Surgery, University of Valencia (MPA-N), Department Anesthesiology, Hospital Universitario y Politécnico la Fe, Perioperative Medicine Research, Health Research Institute Hospital la Fe, Faculty of Mathematical Sciences, University of Valencia, Valencia, Spain (GM), LMU Klinikum, Ludwig Maximilians-University München, München, Germany (ST), Department Anesthesiology. Hospital Universitario y Politécnico la Fe, Perioperative Medicine Research, Health Research Institute Hospital la Fe, Valencia, Spain (NG-G), Jessa Hospital, Hasselt, Belgium, Hasselt University, Hasselt, Belgium (JV), Department of Anaesthesiology and Intensive Care, Hôpital Européen Georges Pompidou, AP-HP, Paris, Université Paris Cité, INSERM UMR-S1140 "Innovations Thérapeutiques en Hémostase", Paris, France (DZ), Department of Anaesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus Dresden, Technische Universität Dresden, Dresden (JW), Medical Scientific Affairs (SS), Medical Scientific Affairs, Hospital Care Division, B. Braun Melsungen AG, Melsungen (SR), BU Pharma & Nutrition, Medical Scientific Affairs, Safety in Clinical Trials & Data Management (CG), BU Pharma & Nutrition, Medical Scientific Affairs, Clinical Operations & Medical Writing (MH), BU Pharma & Nutrition, Global Regulatory Affairs, Regulatory Writing (CJ), BU Pharma & Nutrition, Medical Scientific Affairs, Clinical Operations & Medical Writing, Fresenius Kabi Deutschland GmbH Bad Homburg, Germany (UN), Center for Outcomes Research and Department of Anesthesiology, UTHealth, Houston, Texas, USA (DIS), and BU Pharma & Nutrition, Medical Scientific Affairs, Fresenius Kabi Deutschland GmbH, Bad Homburg, Germany (MW).
发现基乙烯粉 (HES) 在外科手术期间的使用在维持大手术患者的功能方面不低于晶质. 这项研究提供了证据,证明HES在按指示使用时耐受性良好.
科学领域:
- 麻醉学和重症监护医学
- 腎臟病學 (nephrology) 是一種醫學.
- 手术流体管理手术流体管理
背景情况:
- 基乙醇粉 (HES) 是一种常见的流体,用于在大手术期间维持血管体积.
- 虽然高剂量,长期使用HES治疗败血症与损伤有关,但目前手术患者的分析显示没有这种影响.
- 这项研究探讨了手术前期HES在外科手术中的安全性和有效性.
研究的目的:
- 为了确定外科手术期间的基乙烯粉 (HES) 是否在预防急性损伤方面不劣于晶质.
- 评估HES在损伤恶化和主要并发症和术后90天死亡率的综合性方面的非劣势.
主要方法:
- 一个随机的,双盲的多中心试验,涉及1985年接受选择性腹部手术的成年患者.
- 患者接受了6%的HES 130/0.4或晶体溶液,剂量取决于血液动力学变量.
- 主要结局是前3个术后天基于囊素C的eGFR的变化;关键的次要结局是90天死亡率和重大并发症的组合.
主要成果:
- 在外科手术期间使用的HES在短期功能方面与水晶类药物无差 (平均eGFR变化: -3.4mL/min/1.73m2与 -1.0mL/min/1.73m2;P<0.001无差).
- 死亡率和重大并发症的90天复合终点发生在两组35%的患者中.
- 没有观察到安全终点的临床显著差异,包括90天的功能. 一年死亡率在各组之间也没有显著差异.
结论:
- 术后的HES在短期功能和90天死亡率和重大并发症的复合终点方面与晶体质无劣.
- 菲尼克斯试验提供了强有力的证据,支持HES的耐受性良好,标签内外科术前使用.
- 研究结果表明,在研究的手术患者群体中,HES可以安全地使用.
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