[en] [en] BACKGROUND: The international multi-center randomized controlled STEPCARE-trial will investigate optimal management of sedation, temperature, and mean arterial pressure (MAP) during intensive care in out-of-hospital cardiac arrest (OHCA) patients due to various etiologies. The primary outcome is mortality at 6 months. This protocol describes an extended follow-up sub-study of the STEPCARE-trial with the main objective to provide detailed long-term outcomes for survivors and caregivers. It will focus on potential neuroprotection and improved recovery for different targets of sedation, temperature, and MAP management at 6 and 12 months post-OHCA.
METHODS: All survivors and one caregiver per survivor at selected STEPCARE sites will be invited to participate. Randomization is stratified by site. This sub-study extends the main STEPCARE follow-up at 6 months by undertaking detailed assessments, face-to-face meetings, inclusion of a caregiver, and repeating the assessments at 12 months. Our main outcome for survivors is cognitive function measured by the Montreal Cognitive Assessment, and for caregivers, the caregiver burden measured by the Zarit Burden Interview. Additional outcomes include symptoms of anxiety, depression, post-traumatic stress disorder, fatigue, physical function, life satisfaction, and life impact (disability), assessed by psychometrically robust measures. The estimated sample size is 600. Efforts to improve interrater reliability and decrease missing data are integral to the study design.
CONCLUSION: These detailed long-term outcomes will explore the possible benefits or risks of fever, sedation, and blood pressure management in post-OHCA survivors. Additionally, this study will explore survivorship after cardiac arrest from various perspectives, including different causes of arrest.
CLINICALTRIALS: gov: NCT0207942.
Disciplines :
Anesthesia & intensive care
Author, co-author :
Lilja, Gisela ; Department of Clinical Sciences, Lund University, Lund, Sweden ; Department of Neurology, Skåne University Hospital, Lund, Sweden
Töniste, Dorit; Department of Clinical Sciences, Lund University, Lund, Sweden ; Department of Neurology, Skåne University Hospital, Lund, Sweden
Bass, Frances; Critical Care Program, The George Institute for Global Health, University of New South Wales (UNSW) Sydney, Sydney, New South Wales, Australia ; Royal North Shore Hospital, Sydney, New South Wales, Australia
Jakobsen, Janus Christian; Copenhagen Trial Unit, Centre for Clinical Intervention Research Capital Region of Denmark, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark ; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Copenhagen, Denmark
Nielsen, Niklas; Department of Clinical Sciences, Lund University, Lund, Sweden ; Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden
Skrifvars, Markus B; Department of Anesthesia and Intensive Care Medicine, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
Ullén, Susann; Clinical Studies Sweden Forum South, Skåne University Hospital, Lund, Sweden
Dankiewicz, Josef; Department of Clinical Sciences, Lund University, Lund, Sweden ; Department of Cardiology, Skåne University Hospital, Lund, Sweden
Levin, Helena; Department of Clinical Sciences, Lund University, Lund, Sweden ; Department of Research, Development, Education and Innovation, Skåne University Hospital, Lund, Sweden
Hästbacka, Johanna; Department of Anesthesia and Intensive Care, Tampere University Hospital, Wellbeing Services County of Pirkanmaa, Tampere, Finland ; Tampere University, Faculty of Medicine and Health Technology, Tampere, Finland
Knappe, Marion Moseby ; Department of Clinical Sciences, Lund University, Lund, Sweden ; Department of Rehabilitation Medicine, Skåne University Hospital, Lund, Sweden
Saxena, Manoj; Critical Care Program, The George Institute for Global Health, University of New South Wales (UNSW) Sydney, Sydney, New South Wales, Australia ; St George Hospital Clinical School, University of New South Wales, Sydney, New South Wales, Australia
Wise, Matt P; Adult Critical Care, University Hospital of Wales, Cardiff, UK
Young, Paul; 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
Aneman, Anders ; 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
Ameloot, Koen; Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium
Cole, Jade M; Adult Critical Care, University Hospital of Wales, Cardiff, UK
Cronberg, Tobias; Department of Clinical Sciences, Lund University, Lund, Sweden ; Department of Neurology, Skåne University Hospital, Lund, Sweden
Delaney, Anthony; Critical Care Program, The George Institute for Global Health, University of New South Wales (UNSW) Sydney, Sydney, New South Wales, Australia ; Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, Sydney, New South Wales, Australia ; Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
Druwé, Patrick; Department of Clinical Sciences, Lund University, Malmö, Sweden ; Department of Anesthesia and Intensive Care, Skåne University Hospital, Malmö, Sweden
During, Joachim; Department of Intensive Care Medicine, Ghent University Hospital, Ghent, Belgium
Graf, Tobias ; University Heart Center Lübeck, Medical Clinic II (Cardiology/Angiology/Intensive Care Medicine), Lübeck, Germany ; German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany
Haenggi, Matthias; Institute of Intensive Care Medicine, University Hospital Zurich, Zurich, Switzerland
Heimburg, Katarina; Department of Clinical Sciences, Lund University, Lund, Sweden ; Department of Cardiology, Skåne University Hospital, Lund, Sweden
Itens, Manuela; Department of Intensive Care Medicine, Inselspital, University Hospital Bern, Bern, Switzerland
Barkholt, Caroline Kamp ; Copenhagen Trial Unit, Centre for Clinical Intervention Research Capital Region of Denmark, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
Keeble, Thomas R ; Essex Cardiothoracic Centre, Essex, UK ; Anglia Ruskin School of Medicine and MTRC, Essex, UK
Leithner, Christoph; Department of Neurology and Experimental Neurology, Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt- Universität Zu Berlin, Berlin, Germany
Lybeck, Anna ; Department of Clinical Sciences, Lund University, Lund, Sweden ; Department of Anesthesia and Intensive Care, Skåne University Hospital, Lund, Sweden
Lundin, Andreas; Department of Anesthesiology and Intensive Care Medicine, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
McGuigan, Peter ; Regional Intensive Care Unit, Royal Victoria Hospital, Belfast, UK ; Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK
Mengel, Annerose; Department of Neurology and Stroke, University Tuebingen, Tuebingen, Germany
Oksanen, Tuomas; Department of Anesthesia and Intensive Care Medicine, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
Ridgway, John; Occupational Therapy Department, St Bartholomew's Hospital, Barts Health NHS Trust, London, UK
Romundstad, Luis ; Department of Anesthesia and Intensive Care Medicine, Division of Emergencies and Critical Care Oslo University Hospital, Oslo, Norway
Schrag, Claudia; Clinic for Intensive Care Medicine, HOCH Cantonal Hospital St. Gallen, St. Gallen, Switzerland
STAMMET, Pascal ; University of Luxembourg ; Department of Anesthesia and Intensive Care, Centre Hospitalier De Luxembourg, Luxembourg, Luxembourg ; Department of Life Sciences and Medicine, Faculty of Science, Technology and Medicine, Esch-sur-Alzette, Luxembourg
Tippett, Anna; Critical Care Program, The George Institute for Global Health, University of New South Wales (UNSW) Sydney, Sydney, New South Wales, Australia
Thomas, Matthew; Department of Intensive Care Medicine, University Hospitals, Bristol and Weston, Bristol, UK
Tirkkonen, Joonas; Department of Anesthesia and Intensive Care, Tampere University Hospital, Wellbeing Services County of Pirkanmaa, Tampere, Finland
Undén, Johan; Department of Clinical Sciences, Lund University, Malmö, Sweden ; Department of Operation and Intensive Care, Halland Hospital, Halmstad, Sweden
Venkatesh, Bala; Critical Care Program, The George Institute for Global Health, University of New South Wales (UNSW) Sydney, Sydney, New South Wales, Australia ; Intensive Care Gold Coast University Hospital, Southport, QLD, Australia
Tiainen, Marjaana; Department of Neurology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
Hammond, Naomi; Critical Care Program, The George Institute for Global Health, University of New South Wales (UNSW) Sydney, Sydney, New South Wales, Australia ; Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, Sydney, New South Wales, Australia
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