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Title: Targeted hypothermia versus targeted Normothermia after out-of-hospital cardiac arrest (TTM2): A randomized clinical trial-Rationale and design.
Austin Authors: Dankiewicz, Josef;Cronberg, Tobias;Lilja, Gisela;Jakobsen, Janus Christian;Bělohlávek, Jan;Callaway, Clifton;Cariou, Alain;Eastwood, Glenn M ;Erlinge, David;Hovdenes, Jan;Joannidis, Michael;Kirkegaard, Hans;Kuiper, Michael;Levin, Helena;Morgan, Matt P G;Nichol, Alistair D;Nordberg, Per;Oddo, Mauro;Pelosi, Paolo;Rylander, Christian;Saxena, Manoj;Storm, Christian;Taccone, Fabio;Ullén, Susann;Wise, Matthew P;Young, Paul;Friberg, Hans;Nielsen, Niklas
Affiliation: Lund University, Skåne University Hospital, Department of Clinical Sciences, Cardiology, Lund, Sweden
Lund University, Skåne University Hospital, Department of Clinical Sciences, Neurology, Lund, Sweden
University College Dublin- Clinical Research Centre, St Vincent's University Hospital Dublin, Ireland; Australian and New Zealand Intensive Care-Research Centre, Monash University, Melbourne. Australia and Dept of Critical Care, Alfred Hospital, Melbourne, Australia
Department of Intensive Care, Austin Health, Heidelberg, Victoria, Australia
Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin Berlin, Germany and Division of Neuroscience Critical Care, Department of Anesthesiology and Critical Care Medicin, Johns Hopkins University School of Medicine, Baltimore, MD, USA
Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA, USA
Division of Critical Care and Trauma, George Institute for Global Health. Intensive Care Unit, St George Hospital, Sydney, Australia
Lund University, Skåne University Hospital, Department of Clinical Sciences, Neurology, Lund, Sweden
The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark
2nd Department of Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic
Medical Intensive Care Unit, Cochin University Hospital (APHP) and Paris Descartes University, Paris, France
Lund University, Skåne University Hospital, Department of Clinical Sciences, Cardiology, Lund, Sweden
Department of Anesthesia and Intensive Care, Oslo University Hospital, Rikshospitalet, Oslo, Norway
Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Innsbruck, Austria
Research Center for Emergency Medicine, Department of Clinical Medicine, Aarhus University Hospital and Aarhus University, Aarhus N, Denmark
Department of Intensive Care, Medical Center Leeuwarden, Leeuwarden, Netherlands
Department of Research & Education, Lund University and Skåne University Hospital
Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom
Section of Cardiology, Stockholm, South General Hospital, Stockholm, Sweden
Department of Intensive Care Medicine, Centre Hospitalier Universitaire Vaudois (CHUV)-University Hospital, University of Lausanne, Faculty of Biology and Medicine
Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, University of Genoa, Genoa, Italy
Department of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium
Clinical Studies Sweden, Skåne University Hospital, Lund, Sweden
Adult Critical Care, University Hospital of Wales, Cardiff, United Kingdom
Medical Research Institute of New Zealand, Wellington, New Zealand
Lund University, Skåne University Hospital, Department of Clinical Sciences, Anesthesia & Intensive care, Lund, Sweden
Lund University, Helsingborg Hospital, Department of Clinical Sciences Lund, Anesthesia & Intensive care, Lund, Sweden
Issue Date: 26-Jun-2019
Date: 2019-06-26
Publication information: American heart journal 2019; 217: 23-31
Abstract: Less than 500 participants have been included in randomized trials comparing hypothermia with regular care for out-of-hospital cardiac arrest patients, and many of these trials were small and at a high risk of bias. Consequently, the accrued data on this potentially beneficial intervention resembles that of a drug following small phase II trials. A large confirmatory trial is therefore warranted. The TTM2-trial is an international, multicenter, parallel group, investigator-initiated, randomized, superiority trial in which a target temperature of 33°C after cardiac arrest will be compared with a strategy to maintain normothermia and early treatment of fever (≥37.8°C). Participants will be randomized within 3 hours of return of spontaneous circulation with the intervention period lasting 40 hours in both groups. Sedation will be mandatory for all patients throughout the intervention period. The clinical team involved with direct patient care will not be blinded to allocation group due to the inherent difficulty in blinding the intervention. Prognosticators, outcome-assessors, the steering group, the trial coordinating team, and trial statistician will be blinded. The primary outcome will be all-cause mortality at 180 days after randomization. We estimate a 55% mortality in the control group. To detect an absolute risk reduction of 7.5% with an alpha of 0.05 and 90% power, 1900 participants will be enrolled. The main secondary neurological outcome will be poor functional outcome (modified Rankin Scale 4-6) at 180 days after arrest. The TTM2-trial will compare hypothermia to 33°C with normothermia and early treatment of fever (≥37.8°C) after out-of-hospital cardiac arrest.
DOI: 10.1016/j.ahj.2019.06.012
Journal: American heart journal
PubMed URL: 31473324
Type: Journal Article
Appears in Collections:Journal articles

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