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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
J. Holgersson, V. Niemelä, MB. Skrifvars, C. Kamp-Jorgensen, M. Saxena, P. Young, F. Bass, J. Dankiewicz, N. Hammond, J. Hästbacka, H. Levin, G. Lilja, M. Moseby-Knappe, M. Tiainen, M. Reinikainen, A. Ceric, J. Düring, A. Lybeck, D....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu protokol klinické studie, časopisecké články
Grantová podpora
Swedish Research Council
ALF-project funding within the Swedish Health Care
Academy of Finland
Sigrid Jusélius Foundation (Finland)
Hospital district of Helsinki and Uusimaa (Finland)
Medicinska Understödsföreningen Liv och Hälsa (Sweden)
Medical Research Future Fund (Australia)
Health Research Council of New Zealand, and the Clinical Research Programme Directorate of Health Ministry of Health and Social Security (Luxembourg)
PubMed
40222389
DOI
10.1111/aas.70034
Knihovny.cz E-zdroje
- MeSH
- horečka * terapie MeSH
- kardiopulmonální resuscitace * MeSH
- lidé MeSH
- multicentrické studie jako téma MeSH
- randomizované kontrolované studie jako téma MeSH
- tělesná teplota MeSH
- terapeutická hypotermie * přístrojové vybavení MeSH
- zástava srdce mimo nemocnici * terapie komplikace MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
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
Anesthesia and Intensive Care Department of Clinical Sciences Lund Lund University Lund Sweden
Anglia Ruskin School of Medicine and MTRC Essex UK
CEDAR Cardiff and Vale University Health Board Cardiff UK
Critical Care and Perioperative Medicine Group Queen Mary University of London London UK
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 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 Anesthesia and Intensive Care Helsingborg Hospital Helsingborg Sweden
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 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 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 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 Research Development Education and Innovation Skåne University Hospital Lund Sweden
Dipartimento di Scienze Chirurgiche Diagnostiche Integrate University of Genova Genova Italy
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 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
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 Heart Center Lübeck University Hospital Schleswig Holstein Lübeck Germany
University of Eastern Finland Institute of Clinical Medicine
Wellcome Wolfson Institute for Experimental Medicine Queen's University Belfast Belfast UK
Yong Loo Lin School of Medicine National University of Singapore Singapore
Citace poskytuje Crossref.org
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