[en] [en] BACKGROUND: Basic management for patients who have suffered a cardiac arrest and are admitted to an intensive care unit (ICU) after resuscitation includes setting targets for blood pressure and managing sedation and temperature. However, optimal targets and management are unknown.
METHODS: The STEPCARE (Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation) trial is a multicenter, parallel-group, randomized, factorial, superiority trial in which sedation, temperature, and blood pressure strategies will be studied in three separate comparisons (SED-CARE, TEMP-CARE, and MAP-CARE). The trial population will be adults admitted to intensive care who are comatose after resuscitation from out-of-hospital cardiac arrest. The primary outcome will be all-cause mortality, and the secondary outcomes will be poor functional outcome (modified Rankin Scale 4-6), Health-Related Quality of Life using EQ-VAS, and specific serious adverse events in the intensive care unit predefined for each trial. All outcomes will be assessed at 6 months after randomization. The prognosticators, outcome assessors, statisticians, data managers, steering group, and manuscript writers will be blinded to treatment allocation. This statistical analysis plan includes a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Analyses will be conducted according to the intention-to-treat principle, that is, all randomized participants with available data will be included. The analyses will be performed independently by two statisticians following the present plan.
CONCLUSION: This statistical analysis plan describes the statistical analyses for the STEPCARE trial in detail. The aim of this predefined statistical analysis plan is to minimize the risk of analysis bias.
Disciplines :
Anesthesia & intensive care
Author, co-author :
Kamp, C B; Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen Ø, Denmark ; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
Dankiewicz, J; Department of Clinical Sciences Lund, Section of Cardiology, Skåne University Hospital, Scania, Sweden
Harboe Olsen, M; Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen Ø, Denmark ; Department of Neuroanaesthesiology, The Neuroscience Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
Holgersson, J; Anesthesiology and Intensive Care, Department of Clinical Sciences, Helsingborg Hospital Lund, Lund University, Lund, Sweden
Saxena, M; Critical Care Division and Department of Intensive Care Medicine, The George Institute for Global Health, Sydney, NSW, Australia ; St George Hospital Clinical School, University of New South Wales, 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
Niemelä, V H ; Department of Anaesthesia and Intensive Care, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
Hästbacka, J; Tampere University Hospital, Wellbeing Services County of Pirkanmaa and Tampere University, Faculty of Medicine and Health Technology, 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
Lilja, G; Department of Neurology and Rehabilitation, Skåne University Hospital, Lund, Sweden ; Neurology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden
Moseby-Knappe, M; Department of Clinical Sciences Lund, Lund University, Lund, Sweden ; Department of Neurology and Rehabilitation, Skåne University Hospital, Lund, Sweden
Tiainen, M; Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
Reinikainen, M; University of Eastern Finland, Institute of Clinical Medicine, Finland ; Department of Anaesthesiology and Intensive Care, Kuopio University Hospital, Finland
Ceric, A ; Anaesthesia & Intensive Care, Department of Clinical Sciences, Lund University, Skåne University Hospital, Malmö, Sweden
Johnsson, J; Department of Anaesthesiology and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden
Undén, J; Department of Operation and Intensive Care, Hallands Hospital Halmstad, Sweden ; Department of Intensive and Perioperative Care, Skåne University Hospital, Lund University, Lund, Sweden
Düring, J; Anaesthesia & Intensive Care, Department of Clinical Sciences, Lund University, Skåne University Hospital, Malmö, Sweden
Lybeck, A ; Department of Intensive and Perioperative Care, Skåne University Hospital, Lund University, Lund, Sweden
Rodriguez-Santos, D; Department of Anaesthesia and Intensive Care, Skaraborgs Sjukhus, Skövde, 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 Institute, Stockholm, Sweden
Grip, J; Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital, Stockholm, Sweden ; Department of Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden
Lotman, E; North Estonia Medical Centre, Estonia
Romundstad, L; Department of Anaesthesia 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 Heart Center Lübeck, University Hospital Schleswig-Holstein, Germany ; German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Lübeck/Kiel, Germany
Mengel, A; Department of Neurology and Stroke, University Hospital Tuebingen, Germany ; Hertie Institute of Clinical Brain Research, Germany
Leithner, C; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität and Humboldt-Universität zu Berlin, Department of Neurology, Berlin, Germany
Nee, J; Department of Nephrology and Medical Intensive Care, Charité - Universitaetsmedizin Berlin, Berlin, Germany
Drúwe, 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, UK ; Regional Intensive Care Unit, Royal Victoria Hospital, Belfast, UK
Ratcliffe, A; Leeds General Infirmary, The Leeds Teaching Hospitals NHS Trust, Leeds, UK
Cole, J; Critical Care, University Hospital of Wales, Cardiff, UK
White, J ; Centre for Healthcare Evaluation, Device Assessment and Research, Cardiff and Vale University, Health Board, Cardiff, UK
Pareek, N; Department of Cardiology, King's College Hospital NHS Foundation Trust, London, UK ; School of Cardiovascular and Metabolic Medicine & Sciences, BHF Centre of Excellence, King's College London, UK
Glover, G; Department of Critical Care, Guy's and St Thomas NHS Foundation Trust, London, UK
Handslip, R; St George's University Hospital NHS Foundation Trust, London, UK
Proudfoot, A; Department of Perioperative Medicine, Barts Heart Centre, St Bartholomew's Hospital, London, UK
Thomas, M; University Hospitals, Bristol and Weston, UK
Pogson, D; Department of Critical Care, Portsmouth University Hospitals Trust, Portsmouth, UK
Keeble, T R; Essex Cardiothoracic Centre, MSE NHSFT, Essex, UK ; Anglia Ruskin School of Medicine & MTRC, ARU, Essex, UK
Nichol, A; University College Dublin Clinical Research Centre at St Vincent's University Hospital, University College Dublin, Dublin, Ireland ; The Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, Australia ; 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, Genova, Italy ; Dipartimento di Scienze Chirurgiche Diagnostiche Integrate, University of Genova, Italy
Pellis, T; Anaesthesia and Intensive Care, Pordenone Hospital Azienda Sanitaria Friuli Occidentale, Italy
Belohlavek, J; 2nd Department of Internal Medicine, Cardiovascular Medicine, General University Hospital, Prague, Czech Republic ; 1st Faculty of Medicine, Charles University, Prague, Czech Republic ; Institute for Heart Diseases, Wroclaw Medical University, Wrocław, Poland
Smid, O; 2nd Department of Internal Medicine, Cardiovascular Medicine, General University Hospital, Prague, Czech Republic ; 1st Faculty of Medicine, Charles University, Prague, Czech Republic
Rob, D; 2nd Department of Internal Medicine, Cardiovascular Medicine, General University Hospital, Prague, Czech Republic ; 1st Faculty of Medicine, Charles University, 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 Anaesthesia, 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
Li, Q; The George Institute for Global Health, University of New South Wales, Sydney, Australia
Reade, M; Medical School, University of Queensland, Brisbane, Australia
Delaney, A; Medical School, University of Queensland, Brisbane, Australia ; Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St Leonards, Australia ; Northern Clinical School, Sydney Medical School, University of Sydney, Camperdown, New South Wales, Australia
Venkatesh, B; The George Institute for Global Health, Sydney, New South Wales, Australia
Hammond, N; Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St Leonards, Australia ; Critical Care Program, The George Institute for Global Health, UNSW, Sydney, Australia
Bass, F; The George Institute for Global Health, University of New South Wales, Sydney, Australia ; Royal North Shore Hospital, Sydney, Australia
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, South Western Sydney Local Health District, Liverpool, New South Wales, 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, New Zealand
Williams, A; Middlemore Hospital, Auckland, New Zealand
Tirkkonen, J; Intensive Care Unit, Tampere University Hospital, Finland
Oksanen, T; Department of Critical Care, University of Melbourne, Melbourne, Victoria, Australia
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; Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland ; University of Eastern Finland, Institute of Clinical Medicine, Finland
Friberg, H; Intensive and Perioperative Care, Skåne University Hospital, Malmö, Sweden ; Anesthesia and Intensive Care, Department of Clinical Sciences Lund, Lund University, Sweden
Cronberg, T; Department of Research, Development, Education and Innovation, Skåne University Hospital, Lund, Sweden ; Department of Neurology and Rehabilitation, Skåne University Hospital, Lund, Sweden
Skrifvars, M B ; Department of Anaesthesia and Intensive Care, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
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