Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Long-Term Outcomes After Cardiac Arrest : Protocol for the Extended Follow-Up Sub-Study of the STEPCARE Trial

Lilja, Gisela LU ; Töniste, Dorit LU ; Bass, Frances ; Jakobsen, Janus Christian ; Nielsen, Niklas LU orcid ; Skrifvars, Markus B. ; Ullén, Susann LU ; Dankiewicz, Josef LU orcid ; Levin, Helena LU and Hästbacka, Johanna , et al. (2025) In Acta Anaesthesiologica Scandinavica 69(9).
Abstract

Background: The international multi-center randomized controlled STEPCARE-trial will investigate optimal management of sedation, temperature, and mean arterial pressure (MAP) during intensive care in out-of-hospital cardiac arrest (OHCA) patients due to various etiologies. The primary outcome is mortality at 6 months. This protocol describes an extended follow-up sub-study of the STEPCARE-trial with the main objective to provide detailed long-term outcomes for survivors and caregivers. It will focus on potential neuroprotection and improved recovery for different targets of sedation, temperature, and MAP management at 6 and 12 months post-OHCA. Methods: All survivors and one caregiver per survivor at selected STEPCARE sites will be... (More)

Background: The international multi-center randomized controlled STEPCARE-trial will investigate optimal management of sedation, temperature, and mean arterial pressure (MAP) during intensive care in out-of-hospital cardiac arrest (OHCA) patients due to various etiologies. The primary outcome is mortality at 6 months. This protocol describes an extended follow-up sub-study of the STEPCARE-trial with the main objective to provide detailed long-term outcomes for survivors and caregivers. It will focus on potential neuroprotection and improved recovery for different targets of sedation, temperature, and MAP management at 6 and 12 months post-OHCA. Methods: All survivors and one caregiver per survivor at selected STEPCARE sites will be invited to participate. Randomization is stratified by site. This sub-study extends the main STEPCARE follow-up at 6 months by undertaking detailed assessments, face-to-face meetings, inclusion of a caregiver, and repeating the assessments at 12 months. Our main outcome for survivors is cognitive function measured by the Montreal Cognitive Assessment, and for caregivers, the caregiver burden measured by the Zarit Burden Interview. Additional outcomes include symptoms of anxiety, depression, post-traumatic stress disorder, fatigue, physical function, life satisfaction, and life impact (disability), assessed by psychometrically robust measures. The estimated sample size is 600. Efforts to improve interrater reliability and decrease missing data are integral to the study design. Conclusion: These detailed long-term outcomes will explore the possible benefits or risks of fever, sedation, and blood pressure management in post-OHCA survivors. Additionally, this study will explore survivorship after cardiac arrest from various perspectives, including different causes of arrest. ClinicalTrials.gov: NCT0207942.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
caregivers, cognition, follow-up studies, out-of-hospital cardiac arrest, outcomes, randomized controlled trial
in
Acta Anaesthesiologica Scandinavica
volume
69
issue
9
article number
e70114
publisher
Blackwell Munksgaard
external identifiers
  • scopus:105014627785
  • pmid:40856035
ISSN
0001-5172
DOI
10.1111/aas.70114
language
English
LU publication?
yes
id
99d1bf0a-3112-432e-82cf-5534b94976f2
date added to LUP
2025-10-10 13:52:58
date last changed
2025-10-11 03:20:23
@article{99d1bf0a-3112-432e-82cf-5534b94976f2,
  abstract     = {{<p>Background: The international multi-center randomized controlled STEPCARE-trial will investigate optimal management of sedation, temperature, and mean arterial pressure (MAP) during intensive care in out-of-hospital cardiac arrest (OHCA) patients due to various etiologies. The primary outcome is mortality at 6 months. This protocol describes an extended follow-up sub-study of the STEPCARE-trial with the main objective to provide detailed long-term outcomes for survivors and caregivers. It will focus on potential neuroprotection and improved recovery for different targets of sedation, temperature, and MAP management at 6 and 12 months post-OHCA. Methods: All survivors and one caregiver per survivor at selected STEPCARE sites will be invited to participate. Randomization is stratified by site. This sub-study extends the main STEPCARE follow-up at 6 months by undertaking detailed assessments, face-to-face meetings, inclusion of a caregiver, and repeating the assessments at 12 months. Our main outcome for survivors is cognitive function measured by the Montreal Cognitive Assessment, and for caregivers, the caregiver burden measured by the Zarit Burden Interview. Additional outcomes include symptoms of anxiety, depression, post-traumatic stress disorder, fatigue, physical function, life satisfaction, and life impact (disability), assessed by psychometrically robust measures. The estimated sample size is 600. Efforts to improve interrater reliability and decrease missing data are integral to the study design. Conclusion: These detailed long-term outcomes will explore the possible benefits or risks of fever, sedation, and blood pressure management in post-OHCA survivors. Additionally, this study will explore survivorship after cardiac arrest from various perspectives, including different causes of arrest. ClinicalTrials.gov: NCT0207942.</p>}},
  author       = {{Lilja, Gisela and Töniste, Dorit and Bass, Frances and Jakobsen, Janus Christian and Nielsen, Niklas and Skrifvars, Markus B. and Ullén, Susann and Dankiewicz, Josef and Levin, Helena and Hästbacka, Johanna and Knappe, Marion Moseby and Saxena, Manoj and Wise, Matt P. and Young, Paul and Aneman, Anders and Ameloot, Koen and Cole, Jade M. and Cronberg, Tobias and Delaney, Anthony and Druwé, Patrick and During, Joachim and Graf, Tobias and Haenggi, Matthias and Heimburg, Katarina and Itens, Manuela and Barkholt, Caroline Kamp and Keeble, Thomas R. and Leithner, Christoph and Lybeck, Anna and Lundin, Andreas and McGuigan, Peter and Mengel, Annerose and Oksanen, Tuomas and Ridgway, John and Romundstad, Luis and Schrag, Claudia and Stammet, Pascal and Tippett, Anna and Thomas, Matthew and Tirkkonen, Joonas and Undén, Johan and Venkatesh, Bala and Tiainen, Marjaana and Hammond, Naomi}},
  issn         = {{0001-5172}},
  keywords     = {{caregivers; cognition; follow-up studies; out-of-hospital cardiac arrest; outcomes; randomized controlled trial}},
  language     = {{eng}},
  number       = {{9}},
  publisher    = {{Blackwell Munksgaard}},
  series       = {{Acta Anaesthesiologica Scandinavica}},
  title        = {{Long-Term Outcomes After Cardiac Arrest : Protocol for the Extended Follow-Up Sub-Study of the STEPCARE Trial}},
  url          = {{http://dx.doi.org/10.1111/aas.70114}},
  doi          = {{10.1111/aas.70114}},
  volume       = {{69}},
  year         = {{2025}},
}