Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

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

Holgersson, J. LU ; Levin, H. LU ; Lilja, G. LU ; Moseby-Knappe, M. LU ; Ceric, A. LU ; Düring, J. LU orcid ; Lybeck, A. LU orcid ; Unden, J. LU ; Friberg, H. LU and Cronberg, T. LU , et al. (2025) In Acta Anaesthesiologica Scandinavica 69(5). p.70034-70034
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... (More)
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. © 2025 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation. (Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; and (Less)
author collaboration
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
cardiac arrest, feedback‐controlled device, fever, randomized controlled trial, temperature management, Body Temperature, Cardiopulmonary Resuscitation, Fever, Humans, Hypothermia, Induced, Out-of-Hospital Cardiac Arrest, Randomized Controlled Trials as Topic, body temperature, complication, controlled study, devices, human, induced hypothermia, out of hospital cardiac arrest, randomized controlled trial (topic), resuscitation, therapy
in
Acta Anaesthesiologica Scandinavica
volume
69
issue
5
pages
70034 - 70034
publisher
Blackwell Munksgaard
external identifiers
  • scopus:105003513248
  • pmid:40222389
ISSN
1399-6576
DOI
10.1111/aas.70034
language
English
LU publication?
yes
id
a1365b38-c636-441d-870f-47c824547072
date added to LUP
2026-03-10 14:49:55
date last changed
2026-03-11 03:28:10
@article{a1365b38-c636-441d-870f-47c824547072,
  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. © 2025 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.}},
  author       = {{Holgersson, J. and Levin, H. and Lilja, G. and Moseby-Knappe, M. and Ceric, A. and Düring, J. and Lybeck, A. and Unden, J. and Friberg, H. and Cronberg, T. and Nielsen, N.}},
  issn         = {{1399-6576}},
  keywords     = {{cardiac arrest; feedback‐controlled device; fever; randomized controlled trial; temperature management; Body Temperature; Cardiopulmonary Resuscitation; Fever; Humans; Hypothermia, Induced; Out-of-Hospital Cardiac Arrest; Randomized Controlled Trials as Topic; body temperature; complication; controlled study; devices; human; induced hypothermia; out of hospital cardiac arrest; randomized controlled trial (topic); resuscitation; therapy}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{70034--70034}},
  publisher    = {{Blackwell Munksgaard}},
  series       = {{Acta Anaesthesiologica Scandinavica}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1111/aas.70034}},
  doi          = {{10.1111/aas.70034}},
  volume       = {{69}},
  year         = {{2025}},
}