Holgersson Johan, Niemelä V, Skrifvars M B, Kamp-Jorgensen C, Saxena M, Young P, Bass F, Dankiewicz J, Hammond N, Hästbacka J, Levin H, Lilja G, Moseby-Knappe M, Tiainen M, Reinikainen M, Ceric A, Düring J, Lybeck A, Rodriguez-Santos D, Johnsson J, Unden J, Lundin A, Kåhlin J, Grip J, Rosell J, Lotman E M, Navarra L, Crichton B, Knight D, Williams A, Romundstad L, Seidel P, Stammet P, Graf T, Mengel A, Leithner C, Nee J, Druwé P, Ameloot K, Wise M, Riddel J, Ahmed M, Buckel M, Mc Guigan P, Maharaj R, Wyncoll D, Thomas M, White J, Keeble T R, Pogson D, Nichol A, Haenggi M, Hilty M P, Iten M, Schrag C, Nafi M, Joannidis M, Robba C, Pellis T, Belohlavek J, Smid O, Rob D, Arabi Y, Buabbas S, Yew Woon C, Aneman A, Stewart A, Bernard S, Palmer-Simpson C, Simpson N, Ramanan M, Reade M, Delaney A, Venkatesh B, Tirkkonen J, Oksanen T, Kaakinen T, Bendel S, Friberg H, Cronberg T, Jakobsen J, Nielsen N
Department of Clinical Sciences Lund, Anesthesia and Intensive Care, Lund University, Lund, Sweden.
Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden.
Acta Anaesthesiol Scand. 2025 May;69(5):e70034. doi: 10.1111/aas.70034.
Fever is associated with brain injury after cardiac arrest. It is unknown whether fever management with a feedback-controlled device impacts patient-centered outcomes in cardiac arrest patients. This trial aims to investigate fever management with or without a temperature control device after out-of-hospital cardiac arrest.
The TEMP-CARE trial is part of the 2 × 2 × 2 factorial Sedation, TEmperature and Pressure after Cardiac Arrest and REsuscitation (STEPCARE) trial, a randomized, international, multicenter, parallel-group, investigator-initiated, superiority trial that will evaluate sedation strategies, temperature management, and blood pressure targets simultaneously in nontraumatic/nonhemorrhagic out-of-hospital cardiac arrest patients following hospital admission. For the temperature management component of the trial described in this protocol, patients will be randomly allocated to fever management with or without a feedback-controlled temperature control device. For those managed with a device, if temperature ≥37.8°C occurs within 72 h post-randomization the device will be started targeting a temperature of ≤37.5°C. Standard fever treatment, as recommended by local guidelines, including pharmacological agents, will be provided to participants in both groups. The two other components of the STEPCARE trial evaluate sedation and blood pressure 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. A physician blinded to the intervention will determine the neurological prognosis following European Resuscitation Council and European Society of Intensive Care Medicine guidelines. The primary outcome is all-cause mortality at six months post-randomization. To detect a 5.6% absolute risk reduction (90% power, alpha .05), 3500 participants will be enrolled. Secondary outcomes include poor functional outcome at six months, intensive care-related serious adverse events, and overall health status at six months.
The TEMP-CARE trial will investigate if post-cardiac arrest management of fever with or without a temperature control device affects patient-important outcomes after cardiac arrest.
发热与心脏骤停后的脑损伤相关。使用反馈控制设备进行发热管理是否会影响心脏骤停患者以患者为中心的结局尚不清楚。本试验旨在研究院外心脏骤停后使用或不使用温度控制设备进行发热管理的情况。
TEMP-CARE试验是心脏骤停与复苏后镇静、温度和压力（STEPCARE）2×2×2析因试验的一部分，这是一项随机、国际、多中心、平行组、研究者发起的优效性试验，将在非创伤性/非出血性院外心脏骤停患者入院后同时评估镇静策略、温度管理和血压目标。对于本方案中描述的试验温度管理部分，患者将被随机分配至使用或不使用反馈控制温度控制设备进行发热管理。对于使用设备管理的患者，如果在随机分组后72小时内体温≥37.8°C，将启动该设备，目标温度为≤37.5°C。两组参与者均将接受当地指南推荐的包括药物在内的标准发热治疗。STEPCARE试验的其他两个部分评估镇静和血压策略。除STEPCARE试验干预措施外，一般重症监护的所有其他方面将根据参与地点的当地实践进行。一名对干预措施不知情的医生将根据欧洲复苏委员会和欧洲重症监护医学学会的指南确定神经学预后。主要结局是随机分组后6个月的全因死亡率。为检测5.6%的绝对风险降低（90%的检验效能，α=0.05），将招募3500名参与者。次要结局包括6个月时功能结局不良、重症监护相关严重不良事件以及6个月时的总体健康状况。
TEMP-CARE试验将研究心脏骤停后使用或不使用温度控制设备进行发热管理是否会影响心脏骤停后对患者重要的结局。
