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
- PMID: 40222389
- PMCID: PMC11994252
- 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
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.
© 2025 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.
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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