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院外心脏停搏后低温治疗和常温治疗的比较
Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest


Josef Dankiewicz ... 心脑血管疾病 • 2021.06.17
相关阅读
• 心脏停搏后的低温治疗与常温治疗相比无益 • 有不可电击复律心律的心脏停搏患者的目标体温管理 • 儿童院内心脏停搏后的低温治疗

摘要


背景

目前建议对心脏停搏后患者采用目标体温管理,但支持证据的确定性较低

 

方法

在一项对结局进行盲法评估的开放标签试验中,我们将因疑似心脏原因或不明原因院外心脏停搏的1,900例成人昏迷患者随机分组,一组接受33℃目标低温治疗和之后的受控复温,另一组接受常温治疗并对发热(体温≥37.8℃)进行早期治疗。主要结局是6个月时的全因死亡。次要结局包括应用改良Rankin量表评估的6个月时的功能结局。预设亚组是根据性别、年龄、初始心律、至恢复自主循环的时间和入院时是否有休克进行定义。预设不良事件包括肺炎、脓毒症、出血、导致血流动力学损害的心律失常,以及与体温管理装置相关的皮肤并发症。

 

结果

我们在共计1,850例患者中评估了主要结局。6个月时,低温治疗组925例患者中的465例(50%)死亡,而常温治疗组为925例患者中的446例(48%)(低温治疗的相对危险度,1.04;95置信区间[CI],0.94~1.14;P=0.37)。在评估了功能结局的1,747例患者中,低温治疗组881例中的488例(55%)有中重度失能或更严重状况(改良Rankin量表评分≥4分),而常温治疗组为866例中的479例(55%)(低温治疗的相对危险度,1.00;95% CI,0.92~1.09)。预设亚组的结局一致。在低温治疗组中,导致血流动力学损害的心律失常发生率高于常温治疗组(24% vs. 17%,P<0.001)。两组的其他不良事件发生率无显著差异。

 

结论

在院外心脏停搏后昏迷的患者中,低温治疗与常温治疗相比未降低截至6个月时的死亡率(由瑞典研究理事会[Swedish Research Council]等资助,TTM2在ClinicalTrials.gov注册号为NCT02908308)。





作者信息

Josef Dankiewicz, M.D., Ph.D., Tobias Cronberg, M.D., Ph.D., Gisela Lilja, O.T., Ph.D., Janus C. Jakobsen, M.D., Ph.D., Helena Levin, M.Sc., Susann Ullén, Ph.D., Christian Rylander, M.D., Ph.D., Matt P. Wise, M.B., B.Ch., D.Phil., Mauro Oddo, M.D., Alain Cariou, M.D., Ph.D., Jan Bělohlávek, M.D., Ph.D., Jan Hovdenes, M.D., Ph.D., Manoj Saxena, M.B., B.Ch., Ph.D., Hans Kirkegaard, M.D., D.M.Sc., Paul J. Young, M.D., Ph.D., Paolo Pelosi, M.D., Christian Storm, M.D., Ph.D., Fabio S. Taccone, M.D., Ph.D., Michael Joannidis, M.D., Clifton Callaway, M.D., Ph.D., Glenn M. Eastwood, R.N., Ph.D., Matt P.G. Morgan, M.B., B.Ch., Ph.D., Per Nordberg, M.D., Ph.D., David Erlinge, M.D., Ph.D., Alistair D. Nichol, Ph.D., Michelle S. Chew, M.D., Ph.D., Jacob Hollenberg, M.D., Ph.D., Matthew Thomas, M.B., B.Ch., Jeremy Bewley, M.B., B.Ch., Katie Sweet, R.N., B.Sc., Anders M. Grejs, M.D., Ph.D., Steffen Christensen, M.D., Ph.D., Matthias Haenggi, M.D., Anja Levis, M.D., Andreas Lundin, M.D., Joachim Düring, M.D., Simon Schmidbauer, M.D., Thomas R. Keeble, M.B., B.S., M.D., Grigoris V. Karamasis, M.D., Claudia Schrag, M.D., Edith Faessler, M.D., Ondrej Smid, M.D., Ph.D., Michal Otáhal, M.D., Ph.D., Marco Maggiorini, M.D., Pedro D. Wendel Garcia, M.Sc., Paul Jaubert, M.D., Jade M. Cole, R.N., B.Sc., Miroslav Solar, M.D., Ph.D., Ola Borgquist, M.D., Ph.D., Christoph Leithner, M.D., Samia Abed-Maillard, M.Sc., Leanlove Navarra, R.N., B.Sc., Martin Annborn, M.D., Ph.D., Johan Undén, M.D., Ph.D., Iole Brunetti, M.D., Akil Awad, M.D., Peter McGuigan, M.B., B.Ch., Roy Bjørkholt Olsen, M.D., Ph.D., Tiziano Cassina, M.D., Ph.D., Philippe Vignon, M.D., Ph.D., Halvor Langeland, M.D., Theis Lange, Ph.D., Hans Friberg, M.D., Ph.D., and Niklas Nielsen, M.D., Ph.D. for the TTM2 Trial Investigators*
From the Department of Clinical Sciences Lund, Sections of Cardiology (J. Dankiewicz, D.E.), Neurology (T. Cronberg, G.L.), and Anesthesiology and Intensive Care (H. Levin, O.B.), Skåne University Hospital Lund, Lund University and Clinical Studies Sweden — Forum South, Skåne University Hospital (S.U.), Lund; the Department of Clinical Sciences Lund, Section of Anesthesia and Intensive Care, Skåne University Hospital Malmö, Malmö, (J. Düring, S.S., H.F.); the Department of Clinical Sciences Lund, Sections of Anesthesiology and Intensive Care (M.A., N.N.) and Clinical Sciences Helsingborg (N.N.), Helsingborg Hospital, Helsingborg; the Department of Clinical Sciences Lund, Section of Anesthesiology and Intensive Care Lund, Hallands Hospital, Halmstad (J.U.); the Department of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg (C.R., A. Lundin); the Department of Clinical Science and Education, Center for Resuscitation Science, Karolinska Institutet, Södersjukhuset, Stockholm (P.N., J. Hollenberg, A.A.); and the Department of Anesthesiology, Intensive Care, and Acute Medicine, Linköping University, Linköping (M.S.C.) — all in Sweden; Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital (J.C.J.), and the Section of Biostatistics, Faculty of Health and Medical Sciences (T.L.), University of Copenhagen, Copenhagen, the Department of Regional Health Research, the Faculty of Health Sciences, University of Southern Denmark, Odense (J.C.J.), the Research Center for Emergency Medicine, the Department of Clinical Medicine (H.K.), and the Department of Intensive Care (A.M.G., S.C.), Aarhus University Hospital, Aarhus — all in Denmark; Adult Critical Care, University Hospital of Wales, Cardiff (M.P.W., M.P.G.M., J.M.C.), the Department of Intensive Care, Bristol Royal Infirmary, Bristol (M.T., J. Bewley, K.S.), Essex Cardiothoracic Centre, Basildon (T.R.K., G.V.K.), Anglia Ruskin University School of Medicine, Chelmsford, Essex (T.R.K., G.V.K.), and the Department of Anesthesiology and Intensive Care, Royal Victoria Hospital, Belfast (P.M.) — all in the United Kingdom; Neuroscience Critical Care Research Group and Adult Intensive Care Medicine Service, Centre Hospitalier Universitaire Vaudois–Lausanne University Hospital and University of Lausanne, Lausanne (M. Oddo, S.A.-M.), the Departments of Intensive Care Medicine (M.H.) and Anesthesiology and Pain Medicine, Inselspital (A. Levis), Bern University Hospital, University of Bern, Bern, the Intensive Care Department, Kantonsspital St. Gallen, St. Gallen (C. Schrag, E.F.), the Institute of Intensive Care Medicine, University Hospital Zurich, Zurich (M.M., P.D.W.G.), and the Cardiac Anesthesia and Intensive Care Department, Instituto Cardiocentro Ticino, Lugano (T. Cassina) — all in Switzerland; Descartes University of Paris and Cochin University Hospital, Paris (A.C., P.J.), Medical-Surgical Intensive Care Unit, Dupuytren Teaching Hospital, Limoges (P.V.) — all in France; the 2nd Department of Medicine (J. Bělohlávek, O.S.), and the Department of Anesthesiology and Intensive Care Medicine (M. Otáhal), General University Hospital and First Faculty of Medicine, Charles University, Prague, the 1st Department of Internal Medicine–Cardioangiology, University Hospital Hradec Králové, and Faculty of Medicine, Charles University, Hradec Králové (M. Solar) — all in the Czech Republic; the Department of Anesthesiology, Division of Emergencies and Critical Care, Oslo University Hospital, Rikshospitalet, Oslo (J. Hovdenes), the Department of Anesthesiology, Sørlandet Hospital, Arendal (R.B.O.), the Department of Anesthesiology and Intensive Care Medicine, St. Olav’s University Hospital, and the Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim (H. Langeland) — all in Norway; the Division of Critical Care and Trauma, George Institute for Global Health, and Bankstown–Lidcombe Hospital, South Western Sydney Local Health District, Sydney (M. Saxena), and the Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine (G.M.E., A.D.N.), and the Department of Intensive Care, Alfred Health (A.D.N.), Monash University, Melbourne — all in Australia; the Medical Research Institute of New Zealand, Intensive Care Unit, Wellington Hospital, Wellington (P.J.Y., L.N.); the Departments of Surgical Sciences and Integrated Diagnostics (P.P.) and Anesthesiology and Intensive Care, San Martino Policlinico Hospital, IRCCS for Oncology and Neuroscience (P.P., I.B.), University of Genoa, Genoa, Italy; the Department of Nephrology and Medical Intensive Care (C. Storm), and Klinik und Hochschulambulanz für Neurologie (C.L.), Charité Universitätzmedizin, Berlin, Germany; the Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, Brussels (F.S.T.); the Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Innsbruck, Austria (M.J.); the Department of Emergency Medicine, University of Pittsburgh, Pittsburgh (C.C.); and University College Dublin Clinical Research Centre at St. Vincent’s University Hospital, Dublin, Ireland (A.D.N.). Address reprint requests to Dr. Nielsen at the Department of Anesthesiology and Intensive Care, Intensive Care Unit, Helsingborg Hospital, S Vallgatan 5, 251 87, Helsingborg, Sweden, or at niklas.nielsen@med.lu.se. *A complete list of TTM2 Trial Investigators is provided in the Supplementary Appendix, available at NEJM.org.

 

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