Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED‐CARE): A protocol for a randomized clinical trial [* Cross-Reference *]

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Ameldina Ceric; Josef Dankiewicz; Johanna Hästbacka; Paul J. Young; Ville Niemelä; Frances Bass; Markus B. Skrifvars; Naomi Hammond; Manoj Saxena; Hilton Levin; Gisela Lilja; Marion Moseby‐Knappe; Marjaana Tiainen; Matti Reinikainen; Jan Holgersson; Caroline Barkholt Kamp; Matt P. Wise; Peter McGuigan; Judith White; Kevin Sweet; Thomas Keeble; Guy Glover; Philip Hopkins; Christopher Remmington; Jenny Cole; Nikos Gorgoraptis; David Pogson; Philippa Jackson; Joachim Düring; Anna Lybeck; Jesper Johnsson; Johan Undén; Andreas Lundin; Jessica Kåhlin; Jonathan Grip; Eno-Martin Lotman; Luis Romundstad; Philipp Seidel; Pascal Stammet; Tobias Graf; Annerose Mengel; Christoph Leithner; Jens Nee; Patrick Druwé; Koen Ameloot; Alistair D. Nichol; Matthias Hænggi; Matthias P. Hilty; Manuela Iten; Claudia Schrag; Matteo Nafi; Michael Joannidis; Chiara Robba; Tommaso Pellis; Jan Bělohlávek; Daniel Rob; Yaseen M. Arabi; S. Buabbas; Chia Yew Woon; Anders Åneman; A Stewart; Michael C. Reade; Candice Delcourt; Anthony Delaney; M. V. Ramanan; Balasubramanian Venkatesh; L Navarra; Brian Crichton; Alan Williams; David Knight; Joonas Tirkkonen; T. Oksanen; Timo Kaakinen; Stepani Bendel; Hans Friberg; Tobias Cronberg; Janus Christian Jakobsen; Niklas Nielsen, 2026, "Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED‐CARE): A protocol for a randomized clinical trial [* Cross-Reference *]", https://lore.list.lu/citation?persistentId=perma:LIST.WBALQE, LIST Open Repository, V1

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Description	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. (2025-04-03) *This entry has been automatically imported via OpenAlex by LIST harvest scripts. Please refer to https://doi.org/10.1111/aas.70022 for the original and latest version of the publication* (2026-07-01)
Subject	Medicine, Health and Life Sciences
Keyword	Medicine, Sedation, Resuscitation, Anesthesia, Cardiopulmonary resuscitation
License/Data Use Agreement	CC BY 4.0


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Persistent Identifier	perma:LIST.WBALQE
Publication Date	2026-07-06
Title	Continuous deep sedation versus minimal sedation after cardiac arrest and resuscitation (SED‐CARE): A protocol for a randomized clinical trial [* Cross-Reference *]
Other Identifier	https://doi.org/10.1111/aas.70022 OpenAlex ID: https://openalex.org/W4409148186
Author	Ameldina Ceric (Lund University, Skåne University Hospital) - ORCID: https://orcid.org/0000-0001-6846-5961 Josef Dankiewicz (Skåne University Hospital) - ORCID: https://orcid.org/0000-0002-6312-6749 Johanna Hästbacka (Tampere University Hospital, Tampere University) - ORCID: https://orcid.org/0000-0002-3613-7231 Paul J. Young (The University of Melbourne, Wellington Hospital, Australian and New Zealand Intensive Care Society, Medical Research Institute of New Zealand, Monash University) - ORCID: https://orcid.org/0000-0002-3428-3083 Ville Niemelä (University of Helsinki, Helsinki University Hospital) - ORCID: https://orcid.org/0009-0009-5048-4801 Frances Bass (Royal North Shore Hospital, The George Institute for Global Health) - ORCID: https://orcid.org/0000-0003-3826-8558 Markus B. Skrifvars (University of Helsinki, Helsinki University Hospital) - ORCID: https://orcid.org/0000-0002-0341-0262 Naomi Hammond (Royal North Shore Hospital, UNSW Sydney, The George Institute for Global Health, George Institute for Global Health) - ORCID: https://orcid.org/0000-0002-6559-7747 Manoj Saxena (UNSW Sydney, The George Institute for Global Health, St George Hospital) - ORCID: https://orcid.org/0000-0002-0385-6731 Hilton Levin (Lund University, Skåne University Hospital, Innovation Skåne (Sweden)) Gisela Lilja (Lund University, Skåne University Hospital) - ORCID: https://orcid.org/0000-0003-1860-1456 Marion Moseby‐Knappe (Lund University, Skåne University Hospital) - ORCID: https://orcid.org/0000-0001-8160-5957 Marjaana Tiainen (University of Helsinki, Helsinki University Hospital) - ORCID: https://orcid.org/0000-0001-5107-1990 Matti Reinikainen (University of Eastern Finland, Kuopio University Hospital) - ORCID: https://orcid.org/0000-0001-6878-3740 Jan Holgersson (Lund University, Helsingborgs lasarett) - ORCID: https://orcid.org/0000-0003-2202-6511 Caroline Barkholt Kamp (University of Southern Denmark, Copenhagen University Hospital, Rigshospitalet) - ORCID: https://orcid.org/0000-0002-7756-4694 Matt P. Wise (University Hospital of Wales) - ORCID: https://orcid.org/0000-0002-2763-4316 Peter McGuigan (Queen's University Belfast, University of Ulster, Royal Victoria Hospital) Judith White (University Hospital of Wales) - ORCID: https://orcid.org/0000-0002-4557-3393 Kevin Sweet (University Hospitals Bristol NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust) - ORCID: https://orcid.org/0000-0002-9131-347X Thomas Keeble (Essex Cardiothoracic Centre, Anglia Ruskin University) - ORCID: https://orcid.org/0000-0001-8695-7994 Guy Glover (Guy's and St Thomas' NHS Foundation Trust) - ORCID: https://orcid.org/0000-0003-1357-1817 Philip Hopkins (King's College Hospital NHS Foundation Trust, Department of Physiological Sciences) - ORCID: https://orcid.org/0000-0002-3713-8391 Christopher Remmington (King's College London, Guy's and St Thomas' NHS Foundation Trust) - ORCID: https://orcid.org/0000-0001-5600-8368 Jenny Cole (University Hospital of Wales) Nikos Gorgoraptis (Barts Health NHS Trust) - ORCID: https://orcid.org/0000-0002-2588-9235 David Pogson (Portsmouth Hospitals NHS Trust) Philippa Jackson (Leeds Teaching Hospitals NHS Trust) - ORCID: https://orcid.org/0000-0001-8836-6450 Joachim Düring (Lund University, Skåne University Hospital) - ORCID: https://orcid.org/0000-0003-1538-9824 Anna Lybeck (Lund University, Skåne University Hospital) - ORCID: https://orcid.org/0000-0001-7574-3958 Jesper Johnsson (Helsingborgs lasarett) - ORCID: https://orcid.org/0000-0003-0651-3811 Johan Undén (Lund University, Skåne University Hospital, Hallands sjukhus Halmstad) - ORCID: https://orcid.org/0000-0002-8344-5720 Andreas Lundin (University of Gothenburg) - ORCID: https://orcid.org/0000-0002-6623-6847 Jessica Kåhlin (Karolinska University Hospital, Karolinska Institutet) - ORCID: https://orcid.org/0000-0001-5266-5272 Jonathan Grip (Karolinska University Hospital, Karolinska Institutet) - ORCID: https://orcid.org/0000-0001-9735-4160 Eno-Martin Lotman (North Estonia Medical Centre) - ORCID: https://orcid.org/0000-0002-7054-9571 Luis Romundstad (Oslo University Hospital, Lovisenberg Diakonale Høgskole) - ORCID: https://orcid.org/0000-0003-0552-1668 Philipp Seidel (Stavanger University Hospital) Pascal Stammet (Centre Hospitalier de Luxembourg, University of Luxembourg, Luxembourg Institute of Science and Technology) - ORCID: https://orcid.org/0000-0002-0298-1012 Tobias Graf (University Hospital Schleswig-Holstein, German Centre for Cardiovascular Research, University of Lübeck) - ORCID: https://orcid.org/0000-0003-4038-147X Annerose Mengel (Hertie Institute for Clinical Brain Research) - ORCID: https://orcid.org/0000-0002-2399-3020 Christoph Leithner (Humboldt-Universität zu Berlin, Charité - Universitätsmedizin Berlin) - ORCID: https://orcid.org/0000-0002-8277-846X Jens Nee (Charité - Universitätsmedizin Berlin) - ORCID: https://orcid.org/0000-0001-9888-4358 Patrick Druwé (Ghent University Hospital) - ORCID: https://orcid.org/0000-0001-8776-6591 Koen Ameloot (Ziekenhuis Oost-Limburg) - ORCID: https://orcid.org/0000-0001-7071-8825 Alistair D. Nichol (University College Dublin, The Alfred Hospital, Australian and New Zealand Intensive Care Society, St. Vincent's University Hospital, Monash University) - ORCID: https://orcid.org/0000-0002-4771-5615 Matthias Hænggi (University Hospital of Zurich) - ORCID: https://orcid.org/0000-0001-5845-031X Matthias P. Hilty (University Hospital of Zurich) - ORCID: https://orcid.org/0000-0002-2765-881X Manuela Iten (University Hospital of Bern) - ORCID: https://orcid.org/0000-0002-0140-2066 Claudia Schrag (Kantonsspital St. Gallen) Matteo Nafi (Epatocentro Ticino) - ORCID: https://orcid.org/0000-0003-2733-9103 Michael Joannidis (Innsbruck Medical University) - ORCID: https://orcid.org/0000-0002-6996-0881 Chiara Robba (Ospedale Policlinico San Martino) - ORCID: https://orcid.org/0000-0003-1628-3845 Tommaso Pellis (Azienda Unità Sanitaria Locale di Ferrara, Azienda Ospedaliera Santa Maria Degli Angeli) - ORCID: https://orcid.org/0000-0002-3113-6811 Jan Bělohlávek (Charles University, Wroclaw Medical University) - ORCID: https://orcid.org/0000-0001-9455-9224 Daniel Rob (Charles University, General University Hospital in Prague) - ORCID: https://orcid.org/0000-0002-3927-2674 Yaseen M. Arabi (King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center) - ORCID: https://orcid.org/0000-0001-5735-6241 S. Buabbas (Al-Sabah Hospital) Chia Yew Woon (National University of Singapore, Nanyang Technological University, Tan Tock Seng Hospital) Anders Åneman (Liverpool Hospital, UNSW Sydney, Ingham Institute, South Western Sydney Local Health District) - ORCID: https://orcid.org/0000-0003-2096-5304 A Stewart (Liverpool Hospital) Michael C. Reade (The University of Queensland, Royal Brisbane and Women's Hospital) - ORCID: https://orcid.org/0000-0003-1570-0707 Candice Delcourt (UNSW Sydney, The George Institute for Global Health, Macquarie University) - ORCID: https://orcid.org/0000-0003-2257-4286 Anthony Delaney (The University of Sydney, Royal North Shore Hospital, The George Institute for Global Health) - ORCID: https://orcid.org/0000-0002-1015-7146 M. V. Ramanan (Queensland University of Technology, Royal Brisbane and Women's Hospital, UNSW Sydney, The George Institute for Global Health) Balasubramanian Venkatesh (The George Institute for Global Health) - ORCID: https://orcid.org/0000-0002-3234-5244 L Navarra (Medical Research Institute of New Zealand) Brian Crichton (Medical Research Institute of New Zealand) Alan Williams (Middlemore Hospital) - ORCID: https://orcid.org/0000-0003-3383-5058 David Knight (Christchurch Hospital) - ORCID: https://orcid.org/0000-0003-2156-4297 Joonas Tirkkonen (Tampere University Hospital, Tampere University) - ORCID: https://orcid.org/0000-0001-7081-4227 T. Oksanen (University of Helsinki, Jorvi Hospital) Timo Kaakinen (Oulu University Hospital, University of Oulu) - ORCID: https://orcid.org/0000-0001-5125-245X Stepani Bendel (University of Eastern Finland, Kuopio University Hospital) Hans Friberg (Lund University, Skåne University Hospital) - ORCID: https://orcid.org/0000-0002-5588-0098 Tobias Cronberg (Lund University, Skåne University Hospital) - ORCID: https://orcid.org/0000-0002-3442-3058 Janus Christian Jakobsen (University of Southern Denmark, Copenhagen University Hospital, Rigshospitalet) - ORCID: https://orcid.org/0000-0002-3642-2120 Niklas Nielsen (Lund University, Helsingborgs lasarett) - ORCID: https://orcid.org/0000-0002-6013-126X
Point of Contact	Use email button above to contact. LIST QDKM (LIST)
Description	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. (2025-04-03) *This entry has been automatically imported via OpenAlex by LIST harvest scripts. Please refer to https://doi.org/10.1111/aas.70022 for the original and latest version of the publication* (2026-07-01)
Subject	Medicine, Health and Life Sciences
Keyword	Medicine Sedation Resuscitation Anesthesia Cardiopulmonary resuscitation
Topic Classification	Cardiac Arrest and Resuscitation Intensive Care Unit Cognitive Disorders Family and Patient Care in Intensive Care Units
Deposit Date	2025-04-03
Data Type	Article
Data Source	Acta Anaesthesiologica Scandinavica

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