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Higher versus lower mean arterial blood pressure after cardiac arrest and resuscitation (MAP-CARE): A protocol for a randomized clinical trial
VH. Niemelä, M. Reinikainen, N. Nielsen, F. Bass, P. Young, G. Lilja, J. Dankiewicz, N. Hammond, J. Hästbacka, H. Levin, M. Moseby-Knappe, M. Saxena, M. Tiainen, A. Ceric, J. Holgersson, CB. Kamp, J. Tirkkonen, T. Oksanen, T. Kaakinen, S. Bendel,...
Language English Country England, Great Britain
Document type Clinical Trial Protocol, Journal Article
Grant support
The Academy of Finland
Sigrid Jusélius Foundation (Finland)
The Swedish Research Council
ALF-project funding within the Swedish Health Care
Health Research Council of New Zealand
Clinical Research Programme Directorate of Health Ministry of Health and Social Security (Luxembourg)
Medicinska Understödsföreningen Liv och Hälsa (Sweden)
Medical Research Future Fund (Australia)
Hospital District of Helsinki and Uusimaa (Finland)
PubMed
40392139
DOI
10.1111/aas.70040
Knihovny.cz E-resources
- MeSH
- Arterial Pressure * physiology MeSH
- Adult MeSH
- Equivalence Trials as Topic MeSH
- Cardiopulmonary Resuscitation * methods MeSH
- Coma etiology MeSH
- Humans MeSH
- Multicenter Studies as Topic MeSH
- Randomized Controlled Trials as Topic MeSH
- Resuscitation * MeSH
- Heart Arrest * therapy physiopathology mortality MeSH
- Treatment Outcome MeSH
- Out-of-Hospital Cardiac Arrest * therapy physiopathology mortality MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial Protocol MeSH
BACKGROUND: In patients resuscitated after cardiac arrest, a higher mean arterial pressure (MAP) may increase cerebral perfusion and attenuate hypoxic brain injury. Here we present the protocol of the mean arterial pressure after cardiac arrest and resuscitation (MAP-CARE) trial aiming to investigate the influence of MAP targets on patient outcomes. METHODS: MAP-CARE is one component of the Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) 2 x 2 x 2 factorial randomized trial. The MAP-CARE trial is an international, multicenter, parallel-group, investigator-initiated, superiority trial designed to test the hypothesis that targeting a higher (>85 mmHg) (intervention) versus a lower (>65 mmHg) (comparator) MAP after resuscitation from cardiac arrest reduces 6-month mortality (primary outcome). Trial participants are adults with sustained return of spontaneous circulation who are comatose following resuscitation from out-of-hospital cardiac arrest. 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 allocation group. The sample size of 3500 participants provides 90% power with an alpha of 0.05 to detect a 5.6 absolute risk reduction in 6-month mortality, assuming a mortality of 60% in the control group. Secondary outcomes will be poor functional outcome 6 months after randomization, patient-reported overall health 6 months after randomization, and the proportion of participants with predefined severe adverse events. CONCLUSION: The MAP-CARE trial will investigate if targeting a higher MAP compared to a lower MAP during intensive care of adults who are comatose following resuscitation from out-of-hospital cardiac arrest reduces 6-month mortality.
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 ARU Essex UK
Bristol Royal Infirmary University Hospitals Bristol and Weston Bristol UK
CEDAR Cardiff and Vale University Health Board Cardiff Cardiff UK
Critical Care Program The George Institute for Global Health UNSW Sydney Australia
Department of Anaesthesiology and Intensive Care Kuopio University Hospital Kuopio Finland
Department of Anesthesia and Intensive Care Helsingborg Hospital Helsingborg Sweden
Department of Anesthesia Critical Care and Pain Medicine Jaber Alahmad Alsabah Hospital Kuwait
Department of Cardiology Royal Prince Alfred Hospital Sydney New South Wales Australia
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 Lund Sweden
Department of Critical Care Portsmouth University Hospitals Trust Cosham 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 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 University Hospital Tuebingen 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 Halmstad Sweden
Department of Perioperative Medicine Barts Heart Centre St Bartholomew's Hospital London UK
Department of Physiology and Pharmacology Karolinska Institutet Stockholm 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 Essex UK
German Center for Cardiovascular Research partner site Hamburg Lübeck Kiel Germany
Guy's and St Thomas' Hospital London UK
Hertie Institute of Clinical Brain Research Tuebingen Germany
Institute for Heart Diseases Wroclaw Medical University Wrocław Poland
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 John Hunter Hospital Newcastle New South Wales Australia
Intensive Care Unit Tampere University Hospital Tampere Finland
Intensive Care Unit Wellington Hospital Wellington New Zealand
IRCCS Policlinico San Martino Genoa Italy
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 Sydney New South Wales Australia
Lovisenberg Diaconal University College Oslo Norway
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
Northern Clinical School Sydney Medical School University of Sydney Sydney New South Wales 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
School of Medicine and Public Health University of Newcastle Newcastle New South Wales Australia
South Western Clinical School University of New South Wales Sydney New South Wales Australia
St George Hospital Clinical School University of New South Wales Sydney New South Wales Australia
St George's University Hospital NHS Foundation Trust London UK
Tan Tock Seng Hospital Singapore Singapore
The Alfred Hospital Melbourne Australia
The George Institute for Global Health Sydney Australia
The Ingham Institute for Applied Medical Research Sydney New South Wales Australia
University Hospital Schleswig Holstein University Heart Center Lübeck Lübeck Germany
Wellcome Wolfson Institute for Experimental Medicine Queen's University Belfast Belfast UK
Yong Loo Lin School of Medicine National University of Singapore Singapore Singapore
References provided by Crossref.org
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