BACKGROUND: Sedation is often provided to resuscitated out-of-hospital cardiac arrest (OHCA) patients to tolerate post-cardiac arrest care, including temperature management. However, the evidence of benefit or harm from routinely administered deep sedation after cardiac arrest is limited. The aim of this trial is to investigate the effects of continuous deep sedation compared to minimal sedation on patient-important outcomes in resuscitated OHCA patients in a large clinical trial. METHODS: The SED-CARE trial is part of the 2 × 2 × 2 factorial Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, a randomized international, multicentre, parallel-group, investigator-initiated, superiority trial with three simultaneous intervention arms. In the SED-CARE trial, adults with sustained return of spontaneous circulation (ROSC) who are comatose following resuscitation from OHCA will be randomized within 4 hours to continuous deep sedation (Richmond agitation and sedation scale (RASS) -4/-5) (intervention) or minimal sedation (RASS 0 to -2) (comparator), for 36 h after ROSC. The primary outcome will be all-cause mortality at 6 months after randomization. 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 the allocation group. To detect an absolute risk reduction of 5.6% with an alpha of 0.05, 90% power, 3500 participants will be enrolled. The secondary outcomes will be the proportion of participants with poor functional outcomes 6 months after randomization, serious adverse events in the intensive care unit, and patient-reported overall health status 6 months after randomization. CONCLUSION: The SED-CARE trial will investigate if continuous deep sedation (RASS -4/-5) for 36 h confers a mortality benefit compared to minimal sedation (RASS 0 to -2) after cardiac arrest.

1st Faculty of Medicine Charles University Prague Institute for Heart Diseases Prauge Czech Republic

2nd Department of Internal Medicine Cardiovascular Medicine General University Hospital Wroclaw Medical University Wroclaw Poland

2nd Department of Medicine Department of Cardiovascular Medicine 1st Faculty of Medicine Charles University Prague and General University Hospital Prague Prague Czech Republic

Adult Critical Care University Hospital of Wales Cardiff UK

Anaesthesia and Intensive Care Pordenone Hospital Azienda Sanitaria Friuli Occidentale Pordenone Italy

Anesthesia and Intensive Care Department of Clinical Sciences Lund Lund University Lund Sweden

Anesthesia and Intensive Care Department of Clinical Sciences Lund Lund University Skane University Hospital Lund Sweden

Anesthesia and Intensive Care Department of Clinical Sciences Lund University Skane University Hospital Malmö Sweden

Anglia Ruskin School of Medicine and MTRC ARU Chelmsford Essex United Kingdom

Australian and New Zealand Intensive Care Research Centre Monash University Melbourne Victoria Australia

BartsHealth NHS Trust London UK

Caboolture and Royal Brisbane and Women's Hospitals Metro North Hospital and Health Service Brisbane Queensland Australia

Charité Universitätsmedizin Berlin Department of Neurology Freie Universität and Humboldt Universität zu Berlin Berlin Germany

Copenhagen Trial Unit Centre for Clinical Intervention Research Copenhagen University Hospital Rigshospitalet Copenhagen Denmark

Copenhagen Trial Unit Centre for Clinical Intervention Research The Capital Region Copenhagen University Hospital Rigshospitalet Copenhagen Denmark

Critical Care Division and Department of Intensive Care Medicine The George Institute for Global Health and St George Hospital Clinical School University of New South Wales Sydney Australia

Critical Care Division The George Institute for Global Health University of New South Wales Sydney New South Wales Australia

Critical Care Program The George Institute for Global Health Malcolm Fisher Depratment of Intensive Care Medicine Royal North Shore Hospital Northern Clinical School Sydney Medical School University of Sydney Sydney Australia

Critical Care Program The George Institute for Global Health UNSW Sydney Australia

Critical Care University Hospital of Wales Cardiff UK

Department of Anaesthesia and Intensive Care Helsinki University Hospital and University of Helsinki Helsinki Finland

Department of Anaesthesia and Intensive Care Jorvi Hospital University Hospital of Helsinki and University of Helsinki Espoo Finland

Department of Anaesthesia and Intensive Care Medicine Centre Hospitalier de Luxembourg Luxembourg Luxembourg

Department of Anaesthesiology and Intensive Care Helsingborg Hospital Helsingborg Sweden

Department of Anaesthesiology and Intensive Care Kuopio University Hospital Kuopio Finland

Department of Anaesthesiology and Intensive Care Medicine Institute of Clinical Sciences Sahlgrenska Academy University of Gothenburg Gothenburg Sweden

Department of Anestesia Critical Care and Pain Medicine Jaber Alahmad Alsabah Hospital Kuwait City Kuwait

Department of Anesthesia and Intensive Care Helsingborg Hospital Helsingborg Sweden

Department of Anesthesia and Intensive Care medicine Division of Emergencies and Critical care Oslo University Hospital Oslo Norway

Department of Cardiology Ziekenhuis Oost Genk Limburg Belgium

Department of Clinical Medicine Faculty of Medicine Health and Human Sciences Macquarie University Sydney Australia

Department of Clinical Science Interventionand Technology Karolinska Institute Stockholm Sweden

Department of Clinical Sciences Anesthesia and Intensive Care Lund University Skåne University Hospital Malmö Sweden

Department of Clinical Sciences Lund Anesthesia and Intensive Care Lund University Lund Sweden

Department of Clinical Sciences Lund Lund University Lund Sweden

Department of Clinical Sciences Lund Section of Cardiology Skåne University Hospital Malmö Sweden

Department of Critical Care Guy's and St Thomas NHS Foundation Trust London UK

Department of Critical Care Portsmouth University Hospitals Trust Portsmouth UK

Department of Critical Care University of Melbourne Melbourne Victoria Australia

Department of Intensive and Perioperative Care Skåne University Hospital Lund University Lund Sweden

Department of Intensive Care Christchurch Hospital Christchurch Central City New Zealand

Department of Intensive Care Medicine Ghent University Hospital Ghent Belgium

Department of Intensive Care Medicine Inselspital University Hospital Bern Bern Switzerland

Department of Intensive Care Medicine Stavanger University Hospital Stavanger Norway

Department of Life Sciences and Medicine Faculty of Science Technology and Medicine University of Luxembourg Esch sur Alzette Luxembourg

Department of Nephrology and Medical Intensive Care Charité Universitaetsmedizin Berlin Berlin Germany

Department of Neurology and Rehabilitation Skåne University Hospital Lund Sweden

Department of Neurology and Stroke University Hospital Tuebingen Hertie Institute of Clinical Brain Research Tuebingen Germany

Department of Neurology Helsinki University Hospital and University of Helsinki Helsinki Finland

Department of Neurology Skåne University Hospital Lund Sweden

Department of Operation and Intensive Care Hallands Hospital Halmstad Sweden

Department of Pharmacy and Adult Critical Care Guy's and St Thomas' NHS Foundation Trust London UK

Department of Physiology and Pharmacology Karolinska Institutet Stockholm Sweden

Department of Regional Health Research Faculty of Health Sciences University of Southern Denmark Odense Denmark

Department of Regional Health Research The Faculty of Health Sciences University of Southern Denmark Odense Denmark

Department of Research Development Education and Innovation Skåne University Hospital Lund Sweden

Division of Intensive Care and Emergency Medicine Department of Internal Medicine Medical University Insbruck Innsbruck Austria

Essex Cardiothoracic Centre MSE NHSFT Essex UK

Faculty of Life Sciences and Medicine King's College Intensive Care Medicine Centre for Human and Applied Physiological Sciences School of Basic and Medical Biosciences London UK

Faculty of Medicine and Health Technology Tampere University Hospital Wellbeing Services County of Pirkanmaa and Tampere University Tampere Finland

Function Perioperative Medicine and Intensive Care Karolinska University Hospital Stockholm Sweden

German Center for Cardiovascular Research Hamburg Lübeck Kiel Germany

Institute of Clinical Medicine University of Eastern Finland Kuopio Finland

Institute of Intensive Care Medicine University Hospital Zurich Zurich Switzerland

Institute of Pharmaceutical Sciences School of Cancer and Pharmaceutical Sciences King's College London London UK

Intensive and Perioperative Care Skåne University Hospital Malmö Sweden

Intensive Care Medicine King's Critical Care King's College Hospital NHS Foundation Trust London UK

Intensive Care Unit Liverpool Hospital South Western Sydney Local Health District Sydney New South Wales Australia

Intensive Care Unit Tampere University Hospital Tampere Finland

Intensive Care Unit Wellington Hospital Wellington New Zealand

IRCCS Policlinico San Martino Genova Italy Dipartimento di Scienze Chirurgiche Diagnostiche Integrate University of Genova Genova Italy

Istituto Cardiocentro Ticino Lugano Switzerland

King Abdullah International Medical Research Center King Saud bin Abdulaziz University for Health Sciences Riyadh Saudi Arabia

Klinik für Intensivmedizin Kantonsspital St Gallen St Gallen Switzerland

Lee Kong Chian School of Medicine Nanyang Technological University Singapore Singapore

Leeds Teaching Hospitals NHS Trust Leeds UK

Liverpool Hospital Liverpool Australia

Lovisenberg Diaconal University College Oslo Norway

Malcolm Fisher Department of Intensive Care Royal North Shore Hospital St Leonards Australia

Medical Research Institute of New Zealand Wellington New Zealand

Medical School University of Queensland Level 9 Health Sciences Building Royal Brisbane and Women's Hospital Brisbane Australia

Middlemore Hospital Auckland New Zealand

Neurology Department of Clinical Sciences Lund Lund University Lund Sweden

North Estonia Medical Centre Tallinn Estonia

OYS Heart Oulu University Hospital MRC Oulu and University of Oulu Oulu Finland

Perioperative Medicine and Intensive Care Karolinska University Hospital Stockholm Sweden

Regional Intensive care Unit Royal Victoria Hospital Belfast United Kingdom

Research Unit of Translational Medicine Research Group of Anaesthesiology Medical Research Center Oulu Oulu University Hospital and University of Oulu Oulu Finland

Royal North Shore Hospital Sydney Australia

School of Clinical Medicine Queensland University of Technology Brisbane Queensland Australia

South Western Clinical School University of New South Wales Sydney New South Wales Australia

Tan Tock Seng Hospital Singapore Singapore

The Alfred Hospital Melbourne Australia

The Australian and New Zealand Intensive Care Research Centre Monash University Melbourne Australia

The George Institute for Global Health Faculty of Medicine University of New South Wales Sydney Australia

The George Institute for Global Health Sydney Australia

The Ingham Institute for Applied Medical Research Sydney New South Wales Australia

University College Dublin Clinical Research Centre at St Vincent's University Hospital University College Dublin Dublin Ireland

University Heart Center Lübeck University Hospital Schleswig Holstein Schleswig Holstein Germany

University Hospitals Bristol and Weston NHS Foundation Trust Bristol UK

Wellcome Wolfson Institute for Experimental Medicine Queen's University Belfast Belfast UK

Yong Loo Lin School of Medicine National University of Singapore Singapore Singapore

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