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, 2025, "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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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
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