Fever management with or without a temperature control device after out-of-hospital cardiac arrest and resuscitation (TEMP-CARE): A study protocol for a randomized clinical trial.
Holgersson, Johan; Niemelä, V; Skrifvars, M Bet al.
2025 • In Acta Anaesthesiologica Scandinavica, 69 (5), p. 70034
cardiac arrest; feedback‐controlled device; fever; randomized controlled trial; temperature management; Humans; Body Temperature; Randomized Controlled Trials as Topic; Out-of-Hospital Cardiac Arrest/therapy; Out-of-Hospital Cardiac Arrest/complications; Fever/therapy; Hypothermia, Induced/instrumentation; Cardiopulmonary Resuscitation
Abstract :
[en] [en] 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.
Disciplines :
Anesthesia & intensive care
Author, co-author :
Holgersson, Johan; Department of Clinical Sciences Lund, Anesthesia and Intensive Care, Lund University, Lund, Sweden ; Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden
Niemelä, V ; Department of Anaesthesia and Intensive Care, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
Skrifvars, M B ; Department of Anaesthesia and Intensive Care, Helsinki University Hospital and University of Helsinki, Helsinki, Finland
Kamp-Jorgensen, C; Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark ; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
Saxena, M; 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
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
Bass, F; Critical Care Program, The George Institute for Global Health, Sydney, Australia ; Royal North Shore Hospital, Sydney, Australia
Dankiewicz, J; Department of Clinical Sciences Lund, Section of Cardiology, Skåne University Hospital, Malmö, Sweden
Hammond, N; Critical Care Program, The George Institute for Global Health, UNSW, Sydney, 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
Lilja, G; Department of Neurology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden ; Department of Neurology, 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
Tiainen, M; Department of Neurology, Helsinki University Hospital and University of Helsinki, Finland
Reinikainen, M; University of Eastern Finland, Institute of Clinical Medicine ; Department of Anaesthesiology and Intensive Care, Kuopio University Hospital
Ceric, A ; Anesthesia and Intensive Care, Department of Clinical Sciences, Lund University, Skane University Hospital, Malmö, Sweden
Düring, J; Anesthesia and Intensive Care, Department of Clinical Sciences, Lund University, Skane University Hospital, Malmö, Sweden
Lybeck, A ; Anesthesia and Intensive Care, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden
Rodriguez-Santos, D; Department of Anaesthesia and Intensive Care, Skaraborgs Sjukhus Skövde, Skaraborg, Sweden
Johnsson, J; Department of Anaesthesiology and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden
Unden, J; Department of Anaesthesiology 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, Solna, Sweden
Grip, J; Function Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden ; Department of Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden
Rosell, J; Department of Anaesthesia and Intensive Care, Central Hospital, Karlstad, Sweden
Lotman, E M; North Estonia Medical Centre, Tallinn, Estonia
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
Romundstad, L; Department of Anesthesia and Intensive Care Medicine, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway ; Department of Anaesthesia and Intensive Care Medicine, 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, Rollingergrund, Luxembourg
Graf, T; University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany
Mengel, A; Department of Neurology and Stroke, University Hospital Tuebingen, Tübingen, Germany ; Department of Neurology and Stroke, Hertie Institute of Clinical Brain Research, Tübingen, Germany
Leithner, C; Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany
Nee, J; Department of Nephrology and Medical Intensive Care, Charité - Universitätsmedizin 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; Adult Critical Care, University Hospital of Wales, Cardiff, UK
Riddel, J; Adult Critical Care, University Hospital of Wales, Cardiff, UK
Ahmed, M; St George's Hospital, London, UK
Buckel, M; Critical Care and Perioperative Medicine Group, Queen Mary University of London, London, UK ; Department of Perioperative Medicine, Bart's Heart Centre, St. Bartholomew's Hospital, London, UK
Mc Guigan, P; Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK ; Regional Intensive Care Unit, Royal Victoria Hospital, Belfast, UK
Maharaj, R; Department of Critical Care Medicine, King's College Hospital, London, UK
Wyncoll, D ; Guy's & St Thomas' NHS Trust, London, UK
Thomas, M; Intensive Care Unit, University Hospitals Bristol and Weston, Bristol
White, J ; CEDAR (Centre for Healthcare Evaluation Device Assessment and Research), Cardiff and Vale University Health Board, Cardiff, UK
Keeble, T R; Essex Cardiothoracic Centre, MSE NHSFT, Essex, UK ; Anglia Ruskin School of Medicine & MTRC, Essex, UK
Pogson, D; Department of Critical Care, Portsmouth University Hospitals Trust, Portsmouth, 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, Lugano, Switzerland
Joannidis, M ; Division of Intensive Care and Emergency Medicine, Department of Internal Medicine, Medical University Insbruck, Innsbruck, Austria
Robba, C; 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
Pellis, T; Anaesthesia and Intensive Care, Pordenone Hospital, Azienda Sanitaria Friuli Occidentale, Pordenone, Italy
Belohlavek, J; Faculty of Medicine, Charles University in Prague, Prague, Czech Republic ; Department of Internal Medicine, Cardiovascular Medicine, General University Hospital, Prague, Czech Republic ; Institute for Heart Diseases, Wroclaw Medical University, Wrocław, Poland
Smid, O; Department of Internal Medicine, Cardiology and Angiology, General University Hospital in Prague, Prague, Czech Republic
Rob, D; Department of Medicine, Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Prague, Czech Republic
Arabi, Y ; Department of Intensive Care, 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, Zahra, Kuwait
Yew Woon, C; Tan Tock Seng Hospital, Singapore ; Yong Loo Lin School of Medicine, National University of Singapore, Singapore ; Lee Kong Chian School of Medicine, Nanyang Technological University, 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 ; Department of Clinical Sciences, The Ingham Institute for Applied Medical Research, Sydney, New South Wales, Australia
Stewart, A; Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District, Sydney, New South Wales, Australia
Bernard, S; The Alfred Hospital, Melbourne, Australia
Palmer-Simpson, C; Critical Care Program, The George Institute for Global Health, Sydney, Australia
Simpson, N; Critical Care Program, The George Institute for Global Health, Sydney, Australia
Ramanan, M; 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 ; Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
Reade, M; Medical School, University of Queensland, Royal Brisbane and Women's Hospital, Brisbane, Australia
Delaney, A; Critical Care Program, The George Institute for Global Health, UNSW, Sydney, Australia ; Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, Sydney, Australia ; Northern Clinical School, Sydney Medical School, University of Sydney, Sydney, Australia
Venkatesh, B; Critical Care Program, The George Institute for Global Health, Sydney, Australia
Tirkkonen, J; Intensive Care Unit, Tampere University Hospital, Tampere, Finland
Oksanen, T; HUS Jorvi Hospital ICU, Esbo, 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; Department of Intensive Care, Kuopio University Hospitals, Kuopio, Finland
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; Department of Neurology, Department of Clinical Sciences Lund, Lund University, Lund, Sweden ; Department of Neurology, Skåne University Hospital, Lund, Sweden
Jakobsen, J; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark ; Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark
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
Fever management with or without a temperature control device after out-of-hospital cardiac arrest and resuscitation (TEMP-CARE): A study protocol for a randomized clinical trial.
