| 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. |
| Authors: |
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, Pascal; 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 |
| Source: |
Acta Anaesthesiologica Scandinavica, 69 (5), e70034 (2025-05) |
| Publisher Information: |
Wiley |
| Publication Year: |
2025 |
| Collection: |
University of Luxembourg: ORBilu - Open Repository and Bibliography |
| Subject Terms: |
cardiac arrest; feedback‐controlled device; fever; randomized controlled trial; temperature management; Humans; Body Temperature; Randomized Controlled Trials as Topic; Out-of-Hospital Cardiac Arrest/therapy; Out-of-Hospital Cardiac Arrest/complications; Fever/therapy; Hypothermia; Induced/instrumentation; Cardiopulmonary Resuscitation; Human health sciences; Anesthesia & intensive care; Sciences de la santé humaine; Anesthésie & soins intensifs |
| Description: |
peer reviewed ; [en] 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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISSN: |
0001-5172; 1399-6576 |
| Relation: |
urn:issn:0001-5172; urn:issn:1399-6576; https://orbilu.uni.lu/handle/10993/64747; info:hdl:10993/64747; https://orbilu.uni.lu/bitstream/10993/64747/1/Holgersson%20Fever%20management%20STEPCARE%20Acta%20Anaesthesiol%20Scand%202025.pdf; info:pmid:40222389 |
| DOI: |
10.1111/aas.70034 |
| Availability: |
https://orbilu.uni.lu/handle/10993/64747; https://orbilu.uni.lu/bitstream/10993/64747/1/Holgersson%20Fever%20management%20STEPCARE%20Acta%20Anaesthesiol%20Scand%202025.pdf; https://doi.org/10.1111/aas.70034 |
| Rights: |
open access ; http://purl.org/coar/access_right/c_abf2 ; info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.AE264280 |
| Database: |
BASE |