Long‐Term Outcomes After Cardiac Arrest: Protocol for the Extended Follow‐Up Sub‐Study of the STEPCARE Trial [* Cross-Reference *]

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Gisela Lilja; Dorit Töniste; Frances Bass; Janus Christian Jakobsen; Niklas Nielsen; Markus B. Skrifvars; Susann Ullén; Josef Dankiewicz; Helena Levin; Johanna Hästbacka; Marion Moseby‐Knappe; Manoj Saxena; Matt P. Wise; Paul J. Young; Anders Åneman; Koen Ameloot; Jade Cole; Tobias Cronberg; Anthony Delaney; Patrick Druwé; Joachim Düring; Tobias Graf; Matthias Hænggi; Katarina Heimburg; Manuela Itens; Caroline Barkholt Kamp; Thomas Keeble; Christoph Leithner; Anna Lybeck; Andreas Lundin; Peter J. McGuigan; Annerose Mengel; Tuomas Oksanen; John P. Ridgway; Luis Romundstad; Claudia Schrag; Pascal Stammet; Anna Tippett; Matthew Thomas; Joonas Tirkkonen; Johan Undén; Balasubramanian Venkatesh; Marjaana Tiainen; Naomi Hammond, 2025, "Long‐Term Outcomes After Cardiac Arrest: Protocol for the Extended Follow‐Up Sub‐Study of the STEPCARE Trial [* Cross-Reference *]", https://lore.list.lu/citation?persistentId=perma:LIST.0MBKZA, LIST Open Repository, V1
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Background: The international multi-center randomized controlled STEPCARE-trial will investigate optimal management of sedation, temperature, and mean arterial pressure (MAP) during intensive care in out-of-hospital cardiac arrest (OHCA) patients due to various etiologies. The primary outcome is mortality at 6 months. This protocol describes an extended follow-up sub-study of the STEPCARE-trial with the main objective to provide detailed long-term outcomes for survivors and caregivers. It will focus on potential neuroprotection and improved recovery for different targets of sedation, temperature, and MAP management at 6 and 12 months post-OHCA. Methods: All survivors and one caregiver per survivor at selected STEPCARE sites will be invited to participate. Randomization is stratified by site. This sub-study extends the main STEPCARE follow-up at 6 months by undertaking detailed assessments, face-to-face meetings, inclusion of a caregiver, and repeating the assessments at 12 months. Our main outcome for survivors is cognitive function measured by the Montreal Cognitive Assessment, and for caregivers, the caregiver burden measured by the Zarit Burden Interview. Additional outcomes include symptoms of anxiety, depression, post-traumatic stress disorder, fatigue, physical function, life satisfaction, and life impact (disability), assessed by psychometrically robust measures. The estimated sample size is 600. Efforts to improve interrater reliability and decrease missing data are integral to the study design. Conclusion: These detailed long-term outcomes will explore the possible benefits or risks of fever, sedation, and blood pressure management in post-OHCA survivors. Additionally, this study will explore survivorship after cardiac arrest from various perspectives, including different causes of arrest. ClinicalTrials.gov: NCT0207942. (2025-08-26)
***This entry has been automatically imported via OpenAlex by LIST harvest scripts. Please refer to https://doi.org/10.1111/aas.70114 for the original and latest version of the publication*** (2026-07-01)
Subject Medicine, Health and Life Sciences
Keyword Medicine, Caregiver burden, Anxiety, Randomized controlled trial, Sedation, Physical therapy, Quality of life (healthcare), Emergency medicine, Psychiatry, Dementia, Internal medicine, Surgery
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