Lilja Gisela, Töniste Dorit, Bass Frances, Jakobsen Janus Christian, Nielsen Niklas, Skrifvars Markus B, Ullén Susann, Dankiewicz Josef, Levin Helena, Hästbacka Johanna, Knappe Marion Moseby, Saxena Manoj, Wise Matt P, Young Paul, Aneman Anders, Ameloot Koen, Cole Jade M, Cronberg Tobias, Delaney Anthony, Druwé Patrick, During Joachim, Graf Tobias, Haenggi Matthias, Heimburg Katarina, Itens Manuela, Barkholt Caroline Kamp, Keeble Thomas R, Leithner Christoph, Lybeck Anna, Lundin Andreas, McGuigan Peter, Mengel Annerose, Oksanen Tuomas, Ridgway John, Romundstad Luis, Schrag Claudia, Stammet Pascal, Tippett Anna, Thomas Matthew, Tirkkonen Joonas, Undén Johan, Venkatesh Bala, Tiainen Marjaana, Hammond Naomi
Department of Clinical Sciences, Lund University, Lund, Sweden.
Department of Neurology, Skåne University Hospital, Lund, Sweden.
Acta Anaesthesiol Scand. 2025 Oct;69(9):e70114. doi: 10.1111/aas.70114.
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.
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.
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.
gov: NCT0207942.
国际多中心随机对照STEPCARE试验将研究因各种病因导致的院外心脏骤停（OHCA）患者在重症监护期间镇静、体温和平均动脉压（MAP）的最佳管理。主要结局是6个月时的死亡率。本方案描述了STEPCARE试验的一项扩展随访子研究，其主要目的是为幸存者和照顾者提供详细的长期结局。它将关注OHCA后6个月和12个月时不同镇静、体温和MAP管理目标的潜在神经保护作用及改善恢复情况。
将邀请选定STEPCARE研究地点的所有幸存者及每位幸存者的一名照顾者参与。随机分组按研究地点进行分层。这项子研究通过进行详细评估、面对面访谈、纳入一名照顾者并在12个月时重复评估，将STEPCARE主要随访时间从6个月延长。我们对幸存者的主要结局是通过蒙特利尔认知评估量表测量的认知功能，对照顾者的主要结局是通过扎里特负担访谈量表测量的照顾者负担。其他结局包括通过心理测量学可靠的方法评估的焦虑、抑郁、创伤后应激障碍、疲劳、身体功能、生活满意度和生活影响（残疾）症状。估计样本量为600。提高评分者间信度和减少缺失数据的努力是研究设计的组成部分。
这些详细的长期结局将探索OHCA后幸存者发热、镇静和血压管理的可能益处或风险。此外，本研究将从各种角度探索心脏骤停后的生存情况，包括不同的心脏骤停原因。
美国国立医学图书馆临床试验注册中心：NCT0207942
