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Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED-CARE): A protocol for a randomized clinical trial
A. Ceric, J. Dankiewicz, J. Hästbacka, P. Young, VH. Niemelä, F. Bass, MB. Skrifvars, N. Hammond, M. Saxena, H. Levin, G. Lilja, M. Moseby-Knappe, M. Tiainen, M. Reinikainen, J. Holgersson, CB. Kamp, MP. Wise, PJ. McGuigan, J. White, K. Sweet,...
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu protokol klinické studie, srovnávací studie, časopisecké články
Grantová podpora
Clinical Research Programme Directorate of Health Ministry of Health and Social Security (Luxembourg)
Hospital district of Helsinki and Uusimaa (Finland)
Health Research Council of New Zealand
(8137)
Sigrid Juséliuksen Säätiö
Medicinska Understödsföreningen Liv och Hälsa
Vetenskapsrådet
ALF-project funding within the Swedish Health Care
(341277)
The Academy of Finland
(199449)
Medical Research Future Fund
(8137)
The Sigrid Jusélius Foundation (Finland)
Medical Research Future Fund (Australia)
PubMed
40178107
DOI
10.1111/aas.70022
Knihovny.cz E-zdroje
- MeSH
- analgosedace * metody MeSH
- dospělí MeSH
- hluboká sedace * metody MeSH
- kardiopulmonální resuscitace * metody MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- zástava srdce mimo nemocnici * terapie mortalita MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
- srovnávací studie MeSH
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
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 ARU Chelmsford Essex United Kingdom
BartsHealth NHS Trust London UK
Critical Care Program The George Institute for Global Health UNSW Sydney Australia
Critical Care University Hospital of Wales Cardiff UK
Department of Anaesthesiology and Intensive Care Helsingborg Hospital Helsingborg Sweden
Department of Anaesthesiology and Intensive Care Kuopio University Hospital Kuopio Finland
Department of Anesthesia and Intensive Care Helsingborg Hospital Helsingborg Sweden
Department of Cardiology Ziekenhuis Oost Genk Limburg Belgium
Department of Clinical Science Interventionand 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 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 Neurology and Rehabilitation Skåne University Hospital Lund Sweden
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 Research Development Education and Innovation Skåne University Hospital Lund Sweden
Essex Cardiothoracic Centre MSE NHSFT Essex UK
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
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 Tampere University Hospital Tampere Finland
Intensive Care Unit Wellington Hospital Wellington New Zealand
Istituto Cardiocentro Ticino Lugano Switzerland
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
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
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 Sydney Australia
The Ingham Institute for Applied Medical Research Sydney New South Wales Australia
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
Citace poskytuje Crossref.org
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