[en] [en] BACKGROUND: In patients resuscitated after cardiac arrest, a higher mean arterial pressure (MAP) may increase cerebral perfusion and attenuate hypoxic brain injury. Here we present the protocol of the mean arterial pressure after cardiac arrest and resuscitation (MAP-CARE) trial aiming to investigate the influence of MAP targets on patient outcomes.
METHODS: MAP-CARE is one component of the Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) 2 x 2 x 2 factorial randomized trial. The MAP-CARE trial is an international, multicenter, parallel-group, investigator-initiated, superiority trial designed to test the hypothesis that targeting a higher (>85 mmHg) (intervention) versus a lower (>65 mmHg) (comparator) MAP after resuscitation from cardiac arrest reduces 6-month mortality (primary outcome). Trial participants are adults with sustained return of spontaneous circulation who are comatose following resuscitation from out-of-hospital cardiac arrest. The two other components of the STEPCARE trial evaluate sedation and temperature control strategies. Apart from the STEPCARE trial interventions, all other aspects of general intensive care will be according to the local practices of the participating site. Neurological prognostication will be performed according to European Resuscitation Council and European Society of Intensive Care Medicine guidelines by a physician blinded to allocation group. The sample size of 3500 participants provides 90% power with an alpha of 0.05 to detect a 5.6 absolute risk reduction in 6-month mortality, assuming a mortality of 60% in the control group. Secondary outcomes will be poor functional outcome 6 months after randomization, patient-reported overall health 6 months after randomization, and the proportion of participants with predefined severe adverse events.
CONCLUSION: The MAP-CARE trial will investigate if targeting a higher MAP compared to a lower MAP during intensive care of adults who are comatose following resuscitation from out-of-hospital cardiac arrest reduces 6-month mortality.
Disciplines :
Anesthesia & intensive care
Author, co-author :
Niemelä, V H ; Department of Anaesthesia and Intensive Care, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
Reinikainen, M; Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland ; Department of Anaesthesiology and Intensive Care, Kuopio University Hospital, Kuopio, Finland
Nielsen, N; Department of Clinical Sciences Lund, Anesthesia and Intensive Care, Lund University, Lund, Sweden ; Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden
Bass, F; The George Institute for Global Health, Sydney, Australia ; Royal North Shore Hospital, Sydney, Australia
Young, P; Intensive Care Unit, Wellington Hospital, Wellington, New Zealand ; Medical Research Institute of New Zealand, Wellington, New Zealand ; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia ; Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia
Lilja, G; Neurology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden ; Department of Neurology, Skåne University Hospital, Lund, Sweden
Dankiewicz, J; Department of Clinical Sciences Lund, Section of Cardiology, Skåne University Hospital, Lund, Sweden
Hammond, N; Critical Care Program, The George Institute for Global Health, UNSW, Sydney, Australia ; Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, Sydney, New South Wales, Australia
Hästbacka, J; Wellbeing Services County of Pirkanmaa and Tampere University, Faculty of Medicine and Health Technology, Tampere University Hospital, Tampere, Finland
Levin, H; Department of Clinical Sciences Lund, Lund University, Lund, Sweden ; Department of Research, Development, Education and Innovation, Skåne University Hospital, Lund, Sweden
Moseby-Knappe, M; Department of Clinical Sciences Lund, Lund University, Lund, Sweden ; Department of Neurology and Rehabilitation, Skåne University Hospital, Lund, Sweden
Saxena, M; Critical Care Division, Department of Intensive Care Medicine, The George Institute for Global Health, Sydney, Australia ; St George Hospital Clinical School, University of New South Wales, Sydney, New South Wales, Australia
Tiainen, M; Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
Ceric, A ; Anesthesia and Intensive Care, Department of Clinical Sciences, Lund University, Skane University Hospital, Malmö, Sweden
Holgersson, J; Department of Clinical Sciences Lund, Anesthesia and Intensive Care, Lund University, Lund, Sweden ; Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden
Kamp, C B; Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark ; Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Copenhagen, Denmark
Tirkkonen, J; Intensive Care Unit, Tampere University Hospital, Tampere, Finland
Oksanen, T; Department of Anaesthesia and Intensive Care, Jorvi Hospital, University Hospital of Helsinki and University of Helsinki, Helsinki, Finland
Kaakinen, T; Research Unit of Translational Medicine, Research Group of Anaesthesiology, Medical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland ; OYS Heart, Oulu University Hospital, MRC Oulu and University of Oulu, Oulu, Finland
Bendel, S; Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland ; Department of Anaesthesiology and Intensive Care, Kuopio University Hospital, Kuopio, Finland
Düring, J; Department of Clinical Sciences, Anesthesia and Intensive Care, Lund University, Skåne University Hospital, Malmö, Sweden
Lybeck, A ; Anesthesia and Intensive Care, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden
Johnsson, J; Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden
Unden, J; Department of Operation and Intensive Care, Hallands Hospital Halmstad, Halmstad, Sweden ; Department of Intensive and Perioperative Care, Skåne University Hospital, Lund University, Lund, Sweden
Lundin, A ; Department of Anaesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Kåhlin, J; Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital, Stockholm, Sweden ; Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden
Grip, J; Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden ; Department of Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden
Lotman, E; North Estonia Medical Centre, Tallinn, Estonia
Romundstad, L; Department of Anesthesia and Intensive Care Medicine, Division of Emergencies and Critical care, Oslo University Hospital, Oslo, Norway ; Lovisenberg Diaconal University College, Oslo, Norway
Seidel, P; Department of Intensive Care Medicine, Stavanger University Hospital, Stavanger, Norway
STAMMET, Pascal ; University of Luxembourg > Faculty of Science, Technology and Medicine (FSTM) > Department of Life Sciences and Medicine (DLSM) > Medical Education ; Department of Anaesthesia and Intensive Care Medicine Centre, Hospitalier de Luxembourg, Luxembourg, Luxembourg
Graf, T; University Hospital Schleswig-Holstein, University Heart Center Lübeck, Lübeck, Germany ; German Center for Cardiovascular Research (DZHK), partner site Hamburg/Lübeck/Kiel, Germany
Mengel, A; Department of Neurology and Stroke, University Hospital Tuebingen, Tuebingen, Germany ; Hertie Institute of Clinical Brain Research, Tuebingen, Germany
Leithner, C; Department of Neurology, Freie Universität and Humboldt-Universität zu Berlin, Charité-Universitätsmedizin Berlin, Berlin, Germany
Nee, J; Department of Nephrology and Medical Intensive Care, Charité-Universitaetsmedizin Berlin, Berlin, Germany
Druwé, P; Department of Intensive Care Medicine, Ghent University Hospital, Ghent, Belgium
Ameloot, K; Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium
Wise, M P; Adult Critical Care, University Hospital of Wales, Cardiff, UK
McGuigan, P J; Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK ; Regional Intensive Care Unit, Royal Victoria Hospital, Belfast, UK
White, J ; CEDAR (Centre for Healthcare Evaluation, Device Assessment and Research), Cardiff and Vale University Health Board Cardiff, Cardiff, UK
Govier, M; Bristol Royal Infirmary, University Hospitals Bristol and Weston, Bristol, UK
Maccaroni, M; Essex Cardiothoracic Centre, Essex, UK ; Anglia Ruskin School of Medicine, ARU, Essex, UK
Ostermann, M; Guy's & St Thomas' Hospital, London, UK
Hopkins, P; Intensive Care Medicine Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences, Medicine King's College, London, UK ; Intensive Care Medicine, King's Critical Care, King's College Hospital, NHS Foundation Trust, London, UK
Proudfoot, A; Department of Perioperative Medicine, Barts Heart Centre, St Bartholomew's Hospital, London, UK
Handslip, R; St George's University Hospital NHS Foundation Trust, London, UK
Pogson, D; Department of Critical Care, Portsmouth University Hospitals Trust Cosham, Portsmouth, UK
Jackson, P; Leeds Teaching Hospitals NHS Trust, Leeds, UK
Nichol, A; Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Victoria, Australia ; University College Dublin Clinical Research Centre at St Vincent's University Hospital, University College Dublin, Dublin, Ireland ; The Alfred Hospital, Melbourne, Australia
Haenggi, M; Institute of Intensive Care Medicine, University Hospital Zurich, Zurich, Switzerland
Hilty, M P; Institute of Intensive Care Medicine, University Hospital Zurich, Zurich, Switzerland
Iten, M ; Department of Intensive Care Medicine, Inselspital University Hospital Bern, Bern, Switzerland
Schrag, C; Klinik für Intensivmedizin, Kantonsspital St. Gallen, St. Gallen, Switzerland
Nafi, M ; Istituto Cardiocentro Ticino, Lugano, Switzerland
Joannidis, M ; Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Insbruck, Innsbruck, Austria
Robba, C; IRCCS Policlinico San Martino, Genoa, Italy ; Dipartimento di Scienze Chirurgiche Diagnostiche Integrate, University of Genova, Genova, Italy
Pellis, T; Anaesthesia and Intensive Care, Pordenone Hospital Azienda Sanitaria Friuli Occidentale, Pordenone, Italy
Belohlavek, J; 2nd Department of Internal Medicine, Cardiovascular Medicine, General University Hospital, 1st Faculty of Medicine, Charles University in Prague, Prague, Czech Republic ; Institute for Heart Diseases, Wroclaw Medical University, Wrocław, Poland
Rob, D; 2nd Department of Medicine, Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague, General University Hospital in Prague, Prague, Czech Republic
Arabi, Y ; King Saud bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center, Riyadh, Saudi Arabia
Buabbas, S; Department of Anesthesia, Critical Care and Pain Medicine, Jaber Alahmad Alsabah Hospital, Kuwait
Yew Woon, C; Tan Tock Seng Hospital, Singapore, Singapore ; Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore ; Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
Aneman, A ; Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District, Sydney, New South Wales, Australia ; South Western Clinical School, University of New South Wales, Sydney, New South Wales, Australia ; The Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia
Stewart, A; Liverpool Hospital, Sydney, New South Wales, Australia
Arnott, C; The George Institute for Global Health, Sydney, Australia
Ramanan, M; Department of Cardiology, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia ; Caboolture and Royal Brisbane and Women's Hospitals, Metro North Hospital and Health Service, Brisbane, Queensland, Australia ; School of Clinical Medicine, Queensland University of Technology, Brisbane, Queensland, Australia
Panwar, R; Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia ; School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia
Delaney, A; Critical Care Program, The George Institute for Global Health, UNSW, Sydney, Australia ; Malcolm Fisher Department of Intensive Care, Royal North Shore Hospital, Sydney, New South Wales, Australia ; Intensive Care Unit, John Hunter Hospital, Newcastle, New South Wales, Australia
Reade, M; Northern Clinical School, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia
Venkatesh, B; The George Institute for Global Health, Sydney, Australia
Navarra, L; Medical Research Institute of New Zealand, Wellington, New Zealand
Crichton, B; Medical Research Institute of New Zealand, Wellington, New Zealand
Knight, D; Department of Intensive Care, Christchurch Hospital, Christchurch, New Zealand
Williams, A; Middlemore Hospital, Auckland, New Zealand
Friberg, H; Anesthesia and Intensive Care, Department of Clinical Sciences Lund, Lund University, Lund, Sweden ; Intensive and Perioperative Care, Skåne University Hospital, Malmö, Sweden
Cronberg, T; Neurology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden ; Department of Neurology, Skåne University Hospital, Lund, Sweden
Jakobsen, J C; Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark ; Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Copenhagen, Denmark
Skrifvars, M B ; Department of Anaesthesia and Intensive Care, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
The trial is funded by The Swedish Research Council, ALF\u2010project funding within the Swedish Health Care, The Academy of Finland, Sigrid Jus\u00E9lius Foundation (Finland), Hospital District of Helsinki and Uusimaa (Finland), Medicinska Underst\u00F6dsf\u00F6reningen Liv och H\u00E4lsa (Sweden), Medical Research Future Fund (Australia), Health Research Council of New Zealand, and the Clinical Research Programme Directorate of Health Ministry of Health and Social Security (Luxembourg).T. Pellis received lecture fees from BD. C. Leithner received research support from Laerdal Foundation. G. Glover received consulting and speaker fees from Sedana Medical; BD and research grants from Mindray; Sedana Medical. J. Nee received honorarium and travel costs for presentations from BD BARD and Xenios AG. M. Skrifvar received speakers fee from BARD Medical (Ireland) 2022 and he is a member of the editorial board of Acta Anaesthesiologica Scandinavica.
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