BACKGROUND: Fever is associated with brain injury after cardiac arrest. It is unknown whether fever management with a feedback-controlled device impacts patient-centered outcomes in cardiac arrest patients. This trial aims to investigate fever management with or without a temperature control device after out-of-hospital cardiac arrest. METHODS: The TEMP-CARE trial is part of the 2 × 2 × 2 factorial Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial, a randomized, international, multicenter, parallel-group, investigator-initiated, superiority trial that will evaluate sedation strategies, temperature management, and blood pressure targets simultaneously in nontraumatic/nonhemorrhagic out-of-hospital cardiac arrest patients following hospital admission. For the temperature management component of the trial described in this protocol, patients will be randomly allocated to fever management with or without a feedback-controlled temperature control device. For those managed with a device, if temperature ≥37.8°C occurs within 72 h post-randomization the device will be started targeting a temperature of ≤37.5°C. Standard fever treatment, as recommended by local guidelines, including pharmacological agents, will be provided to participants in both groups. The two other components of the STEPCARE trial evaluate sedation and blood pressure 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. A physician blinded to the intervention will determine the neurological prognosis following European Resuscitation Council and European Society of Intensive Care Medicine guidelines. The primary outcome is all-cause mortality at six months post-randomization. To detect a 5.6% absolute risk reduction (90% power, alpha .05), 3500 participants will be enrolled. Secondary outcomes include poor functional outcome at six months, intensive care-related serious adverse events, and overall health status at six months. CONCLUSION: The TEMP-CARE trial will investigate if post-cardiac arrest management of fever with or without a temperature control device affects patient-important outcomes after cardiac arrest.

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 Essex UK

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

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

CEDAR Cardiff and Vale University Health Board Cardiff UK

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 and Perioperative Medicine Group Queen Mary University of London London UK

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 Sydney Australia

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

Department of Anaesthesia and Intensive Care Central Hospital Karlstad Sweden

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

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

Department of Anaesthesia and Intensive Care Medicine Lovisenberg Diaconal University College Oslo Norway

Department of Anaesthesia and Intensive Care Skaraborgs Sjukhus Skövde Skaraborg Sweden

Department of Anaesthesiology and Intensive Care Hallands Hospital Halmstad Halmstad Sweden

Department of Anaesthesiology and Intensive Care Helsingborg Hospital Helsingborg Sweden

Department of Anaesthesiology and Intensive Care Kuopio University Hospital

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

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 Anesthesia Critical Care and Pain Medicine Jaber Alahmad Alsabah Hospital Zahra Kuwait

Department of Cardiology Ziekenhuis Oost Limburg Genk Belgium

Department of Clinical Science Intervention and Technology Karolinska Institute Stockholm 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 Clinical Sciences The Ingham Institute for Applied Medical Research Sydney New South Wales Australia

Department of Critical Care Medicine King's College Hospital 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 New Zealand

Department of Intensive Care King Saud bin Abdulaziz University for Health Sciences and King Abdullah International Medical Research Center Riyadh Saudi Arabia

Department of Intensive Care Kuopio University Hospitals Kuopio Finland

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 Internal Medicine Cardiology and Angiology General University Hospital Prague Prague Czech Republic

Department of Internal Medicine Cardiovascular Medicine General University Hospital Prague Czech Republic

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

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

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

Department of Neurology and Rehabilitation Skåne University Hospital Lund Sweden

Department of Neurology and Stroke Hertie Institute of Clinical Brain Research Tübingen Germany

Department of Neurology and Stroke University Hospital Tuebingen Tübingen Germany

Department of Neurology Charité Universitätsmedizin Berlin Berlin Germany

Department of Neurology Department of Clinical Sciences Lund Lund University Lund Sweden

Department of Neurology Helsinki University Hospital and University of Helsinki Finland

Department of Neurology Skåne University Hospital Lund Sweden

Department of Perioperative Medicine Bart's Heart Centre St Bartholomew's Hospital London UK

Department of Physiology and Pharmacology Karolinska Institutet Solna Sweden

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

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

Dipartimento di Scienze Chirurgiche Diagnostiche Integrate University of Genova Genova Italy

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 Medicine Charles University Prague Prague Czech Republic

Function Perioperative Medicine and Intensive Care Karolinska University Hospital Stockholm Sweden

Guy's and St Thomas' NHS Trust London UK

HUS Jorvi Hospital ICU Esbo Finland

Institute for Heart Diseases Wroclaw Medical University Wrocław Poland

Institute of Intensive Care Medicine University Hospital Zurich Zurich Switzerland

Intensive and Perioperative Care Skåne University Hospital Malmö Sweden

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 University Hospitals Bristol and Weston Bristol

Intensive Care Unit Wellington Hospital Wellington New Zealand

Istituto Cardiocentro Ticino Lugano Lugano Switzerland

Klinik für Intensivmedizin Kantonsspital St Gallen St Gallen Switzerland

Lee Kong Chian School of Medicine Nanyang Technological University Singapore

Malcolm Fisher Department of Intensive Care Medicine Royal North Shore Hospital Sydney Australia

Medical Research Institute of New Zealand Wellington New Zealand

Medical School University of Queensland Royal Brisbane and Women's Hospital Brisbane Australia

Middlemore Hospital Auckland New Zealand

North Estonia Medical Centre Tallinn Estonia

Northern Clinical School Sydney Medical School University of Sydney Sydney Australia

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 UK

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

St George's Hospital London UK

Tan Tock Seng Hospital Singapore

The Alfred Hospital Melbourne 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 Lübeck Germany

University of Eastern Finland Institute of Clinical Medicine

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

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

Yong Loo Lin School of Medicine National University of Singapore Singapore

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