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

Gisela Lilja; Dorit Töniste; Frances Bass; Janus Christian Jakobsen; Niklas Nielsen; Markus B Skrifvars; Susann Ullén; Josef Dankiewicz; Helena Levin; Johanna Hästbacka; Marion Moseby Knappe; Manoj Saxena; Matt P Wise; Paul Young; Anders Aneman; Koen Ameloot; Jade M Cole; Tobias Cronberg; Anthony Delaney; Patrick Druwé; Joachim During; Tobias Graf; Matthias Haenggi; Katarina Heimburg; Manuela Itens; Caroline Kamp Barkholt; Thomas R Keeble; Christoph Leithner; Anna Lybeck; Andreas Lundin; Peter McGuigan; Annerose Mengel; Tuomas Oksanen; John Ridgway; Luis Romundstad; Claudia Schrag; Pascal Stammet; Anna Tippett; Matthew Thomas; Joonas Tirkkonen; Johan Undén; Bala Venkatesh; Marjaana Tiainen; Naomi Hammond

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

Gisela Lilja, Dorit Töniste, Frances Bass, Janus Christian Jakobsen, Niklas Nielsen, Markus B Skrifvars, Susann Ullén, Josef Dankiewicz, Helena Levin, Johanna Hästbacka, Marion Moseby Knappe, Manoj Saxena, Matt P Wise, Paul Young, Anders Aneman, Koen Ameloot, Jade M Cole, Tobias Cronberg, Anthony Delaney, Patrick DruwéJoachim During, Tobias Graf, Matthias Haenggi, Katarina Heimburg, Manuela Itens, Caroline Kamp Barkholt, Thomas R Keeble, Christoph Leithner, Anna Lybeck, Andreas Lundin, Peter McGuigan, Annerose Mengel, Tuomas Oksanen, John Ridgway, Luis Romundstad, Claudia Schrag, Pascal Stammet, Anna Tippett, Matthew Thomas, Joonas Tirkkonen, Johan Undén, Bala Venkatesh, Marjaana Tiainen, Naomi Hammond

Department of Internal Medicine II

1 Citation (Scopus)

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 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.

Original language	English
Article number	e70114
Journal	Acta Anaesthesiologica Scandinavica
Volume	69
Issue number	9
Pages (from-to)	e70114
ISSN	0001-5172
Publication status	Published - 10.2025

Funding

Funders	Funder number
Skåne County Council's Research and Development Foundation
Hans-Gabriel och Alice Trolle-Wachtmeisters stiftelse för medicinsk forskning
Swedish Health Care
Health Research Council of New Zealand
Region Halland
Skånes universitetssjukhus
Vetenskapsrådet
National Health and Medical Research Council	APP2015994
Research Council of Finland	341277

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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Lilja, G., Töniste, D., Bass, F., Jakobsen, J. C., Nielsen, N., Skrifvars, M. B., Ullén, S., Dankiewicz, J., Levin, H., Hästbacka, J., Knappe, M. M., Saxena, M., Wise, M. P., Young, P., Aneman, A., Ameloot, K., Cole, J. M., Cronberg, T., Delaney, A., ... Hammond, N. (2025). Long-Term Outcomes After Cardiac Arrest: Protocol for the Extended Follow-Up Sub-Study of the STEPCARE Trial. Acta Anaesthesiologica Scandinavica, 69(9), e70114. Article e70114.

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

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 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.",

author = "Gisela Lilja and Dorit T{\"o}niste and Frances Bass and Jakobsen, \{Janus Christian\} and Niklas Nielsen and Skrifvars, \{Markus B\} and Susann Ull{\'e}n and Josef Dankiewicz and Helena Levin and Johanna H{\"a}stbacka and Knappe, \{Marion Moseby\} and Manoj Saxena and Wise, \{Matt P\} and Paul Young and Anders Aneman and Koen Ameloot and Cole, \{Jade M\} and Tobias Cronberg and Anthony Delaney and Patrick Druw{\'e} and Joachim During and Tobias Graf and Matthias Haenggi and Katarina Heimburg and Manuela Itens and Barkholt, \{Caroline Kamp\} and Keeble, \{Thomas R\} and Christoph Leithner and Anna Lybeck and Andreas Lundin and Peter McGuigan and Annerose Mengel and Tuomas Oksanen and John Ridgway and Luis Romundstad and Claudia Schrag and Pascal Stammet and Anna Tippett and Matthew Thomas and Joonas Tirkkonen and Johan Und{\'e}n and Bala Venkatesh and Marjaana Tiainen and Naomi Hammond",

note = "{\textcopyright} 2025 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley \& Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.",

year = "2025",

month = oct,

language = "English",

volume = "69",

pages = "e70114",

journal = "Acta Anaesthesiologica Scandinavica",

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Lilja, G, Töniste, D, Bass, F, Jakobsen, JC, Nielsen, N, Skrifvars, MB, Ullén, S, Dankiewicz, J, Levin, H, Hästbacka, J, Knappe, MM, Saxena, M, Wise, MP, Young, P, Aneman, A, Ameloot, K, Cole, JM, Cronberg, T, Delaney, A, Druwé, P, During, J, Graf, T, Haenggi, M, Heimburg, K, Itens, M, Barkholt, CK, Keeble, TR, Leithner, C, Lybeck, A, Lundin, A, McGuigan, P, Mengel, A, Oksanen, T, Ridgway, J, Romundstad, L, Schrag, C, Stammet, P, Tippett, A, Thomas, M, Tirkkonen, J, Undén, J, Venkatesh, B, Tiainen, M & Hammond, N 2025, 'Long-Term Outcomes After Cardiac Arrest: Protocol for the Extended Follow-Up Sub-Study of the STEPCARE Trial', Acta Anaesthesiologica Scandinavica, vol. 69, no. 9, e70114, pp. e70114.

TY - JOUR

T1 - Long-Term Outcomes After Cardiac Arrest

T2 - Protocol for the Extended Follow-Up Sub-Study of the STEPCARE Trial

AU - Lilja, Gisela

AU - Töniste, Dorit

AU - Bass, Frances

AU - Jakobsen, Janus Christian

AU - Nielsen, Niklas

AU - Skrifvars, Markus B

AU - Ullén, Susann

AU - Dankiewicz, Josef

AU - Levin, Helena

AU - Hästbacka, Johanna

AU - Knappe, Marion Moseby

AU - Saxena, Manoj

AU - Wise, Matt P

AU - Young, Paul

AU - Aneman, Anders

AU - Ameloot, Koen

AU - Cole, Jade M

AU - Cronberg, Tobias

AU - Delaney, Anthony

AU - Druwé, Patrick

AU - During, Joachim

AU - Graf, Tobias

AU - Haenggi, Matthias

AU - Heimburg, Katarina

AU - Itens, Manuela

AU - Barkholt, Caroline Kamp

AU - Keeble, Thomas R

AU - Leithner, Christoph

AU - Lybeck, Anna

AU - Lundin, Andreas

AU - McGuigan, Peter

AU - Mengel, Annerose

AU - Oksanen, Tuomas

AU - Ridgway, John

AU - Romundstad, Luis

AU - Schrag, Claudia

AU - Stammet, Pascal

AU - Tippett, Anna

AU - Thomas, Matthew

AU - Tirkkonen, Joonas

AU - Undén, Johan

AU - Venkatesh, Bala

AU - Tiainen, Marjaana

AU - Hammond, Naomi

PY - 2025/10

Y1 - 2025/10

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/105014627785

UR - https://www.mendeley.com/catalogue/fcfcac90-9095-3939-81d0-da577afe80ec/

M3 - Journal articles

C2 - 40856035

SN - 0001-5172

VL - 69

SP - e70114

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

IS - 9

M1 - e70114

ER -

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

Abstract

Funding

UN SDGs

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