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. 2025 May;69(5):e70034.
doi: 10.1111/aas.70034.

Fever management with or without a temperature control device after out-of-hospital cardiac arrest and resuscitation (TEMP-CARE): A study protocol for a randomized clinical trial

Johan Holgersson  1   2 V Niemelä  3 M B Skrifvars  3 C Kamp-Jorgensen  4   5 M Saxena  4   6 P Young  7   8   9   10 F Bass  11   12 J Dankiewicz  13 N Hammond  14 J Hästbacka  15 H Levin  16   17 G Lilja  18   19 M Moseby-Knappe  16   20 M Tiainen  21 M Reinikainen  22   23 A Ceric  24 J Düring  24 A Lybeck  25 D Rodriguez-Santos  26 J Johnsson  27 J Unden  28   29 A Lundin  30 J Kåhlin  31   32 J Grip  33   34 J Rosell  35 E M Lotman  36 L Navarra  8 B Crichton  8 D Knight  37 A Williams  38 L Romundstad  39   40 P Seidel  41 P Stammet  42   43 T Graf  44 A Mengel  45   46 C Leithner  47 J Nee  48 P Druwé  49 K Ameloot  50 M Wise  51 J Riddel  51 M Ahmed  52 M Buckel  53   54 P Mc Guigan  55   56 R Maharaj  57 D Wyncoll  58 M Thomas  59 J White  60 T R Keeble  61   62 D Pogson  63 A Nichol  9   64   65 M Haenggi  66 M P Hilty  66 M Iten  67 C Schrag  68 M Nafi  69 M Joannidis  70 C Robba  71   72 T Pellis  73 J Belohlavek  74   75   76 O Smid  77 D Rob  78 Y Arabi  79 S Buabbas  80 C Yew Woon  81   82   83 A Aneman  84   85   86 A Stewart  84 S Bernard  65 C Palmer-Simpson  11 N Simpson  11 M Ramanan  87   88   89 M Reade  90 A Delaney  14   91   92 B Venkatesh  11 J Tirkkonen  93 T Oksanen  94 T Kaakinen  95   96 S Bendel  97 H Friberg  98   99 T Cronberg  18   19 J Jakobsen  5   100 N Nielsen  1   2
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Fever management with or without a temperature control device after out-of-hospital cardiac arrest and resuscitation (TEMP-CARE): A study protocol for a randomized clinical trial

Johan Holgersson et al. Acta Anaesthesiol Scand. 2025 May.

Abstract

Background: 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.

Methods: 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.

Conclusion: 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.

Keywords: cardiac arrest; feedback‐controlled device; fever; randomized controlled trial; temperature management.

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Conflict of interest statement

Skrifvars MB received a speakers fee from BARD Medical (Ireland) 2022 and is a member of the editorial board of Acta Anaesthesiologica Scandinavica. Leithner C has received research support from the Laerdal Foundation. Nee J received honorarium and travel costs for presentations from BD BARD and Xenios AG. Joannidis M has received consulting fees from Baxter Healthcare Corp, AM‐Phjarma, Biomerieux, Sphingotec and AOP pharma, and honoraria for lectures from Baxter Healthcare Corp, AOP Health and Biomerieux, and grants from Baxter Healthcare and Fresenius. Pellis T has received lecture fees from BD. Reade M is an investigator in several National Health and Medical Research Council—funded trials, including trials of sedative agents and other treatments for brain injury.

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