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Sedation, temperature and pressure after cardiac arrest and resuscitation—The STEPCARE trial: A statistical analysis plan

Kamp, C.B. ; Holgersson, J. LU ; Levin, H. LU ; Lilja, G. LU ; Moseby-Knappe, M. LU ; Ceric, A. LU ; Undén, J. LU ; Düring, J. LU orcid ; Lybeck, A. LU orcid and Friberg, H. LU , et al. (2025) In Acta Anaesthesiologica Scandinavica 69(5).
Abstract
Background: Basic management for patients who have suffered a cardiac arrest and are admitted to an intensive care unit (ICU) after resuscitation includes setting targets for blood pressure and managing sedation and temperature. However, optimal targets and management are unknown. Methods: The STEPCARE (Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation) trial is a multicenter, parallel-group, randomized, factorial, superiority trial in which sedation, temperature, and blood pressure strategies will be studied in three separate comparisons (SED-CARE, TEMP-CARE, and MAP-CARE). The trial population will be adults admitted to intensive care who are comatose after resuscitation from out-of-hospital cardiac arrest. The... (More)
Background: Basic management for patients who have suffered a cardiac arrest and are admitted to an intensive care unit (ICU) after resuscitation includes setting targets for blood pressure and managing sedation and temperature. However, optimal targets and management are unknown. Methods: The STEPCARE (Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation) trial is a multicenter, parallel-group, randomized, factorial, superiority trial in which sedation, temperature, and blood pressure strategies will be studied in three separate comparisons (SED-CARE, TEMP-CARE, and MAP-CARE). The trial population will be adults admitted to intensive care who are comatose after resuscitation from out-of-hospital cardiac arrest. The primary outcome will be all-cause mortality, and the secondary outcomes will be poor functional outcome (modified Rankin Scale 4–6), Health-Related Quality of Life using EQ-VAS, and specific serious adverse events in the intensive care unit predefined for each trial. All outcomes will be assessed at 6 months after randomization. The prognosticators, outcome assessors, statisticians, data managers, steering group, and manuscript writers will be blinded to treatment allocation. This statistical analysis plan includes a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Analyses will be conducted according to the intention-to-treat principle, that is, all randomized participants with available data will be included. The analyses will be performed independently by two statisticians following the present plan. Conclusion: This statistical analysis plan describes the statistical analyses for the STEPCARE trial in detail. The aim of this predefined statistical analysis plan is to minimize the risk of analysis bias. © 2025 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation. (Less)
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publication status
published
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keywords
blood pressure, cardiac arrest, sedation, statistical analysis, STEPCARE trial, temperature, adult, all cause mortality, Article, comatose patient, European Quality of Life 5 Dimensions Visual Analogue Scale, female, human, intensive care unit, intention to treat analysis, male, mean arterial pressure, multicenter study (topic), out of hospital cardiac arrest, outcome assessment, prognosis, quality of life, Rankin scale, resuscitation
in
Acta Anaesthesiologica Scandinavica
volume
69
issue
5
article number
e70033
publisher
Blackwell Munksgaard
external identifiers
  • scopus:105002457457
  • pmid:40210585
ISSN
0001-5172
DOI
10.1111/aas.70033
language
English
LU publication?
yes
id
0d0776cf-77b4-4c62-a58a-3f7625a06717
date added to LUP
2025-12-19 11:24:24
date last changed
2025-12-20 03:26:24
@article{0d0776cf-77b4-4c62-a58a-3f7625a06717,
  abstract     = {{Background: Basic management for patients who have suffered a cardiac arrest and are admitted to an intensive care unit (ICU) after resuscitation includes setting targets for blood pressure and managing sedation and temperature. However, optimal targets and management are unknown. Methods: The STEPCARE (Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation) trial is a multicenter, parallel-group, randomized, factorial, superiority trial in which sedation, temperature, and blood pressure strategies will be studied in three separate comparisons (SED-CARE, TEMP-CARE, and MAP-CARE). The trial population will be adults admitted to intensive care who are comatose after resuscitation from out-of-hospital cardiac arrest. The primary outcome will be all-cause mortality, and the secondary outcomes will be poor functional outcome (modified Rankin Scale 4–6), Health-Related Quality of Life using EQ-VAS, and specific serious adverse events in the intensive care unit predefined for each trial. All outcomes will be assessed at 6 months after randomization. The prognosticators, outcome assessors, statisticians, data managers, steering group, and manuscript writers will be blinded to treatment allocation. This statistical analysis plan includes a comprehensive description of the statistical analyses, handling of missing data, and assessments of underlying statistical assumptions. Analyses will be conducted according to the intention-to-treat principle, that is, all randomized participants with available data will be included. The analyses will be performed independently by two statisticians following the present plan. Conclusion: This statistical analysis plan describes the statistical analyses for the STEPCARE trial in detail. The aim of this predefined statistical analysis plan is to minimize the risk of analysis bias. © 2025 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.}},
  author       = {{Kamp, C.B. and Holgersson, J. and Levin, H. and Lilja, G. and Moseby-Knappe, M. and Ceric, A. and Undén, J. and Düring, J. and Lybeck, A. and Friberg, H. and Nielsen, N. and Jakobsen, J.C.}},
  issn         = {{0001-5172}},
  keywords     = {{blood pressure; cardiac arrest; sedation; statistical analysis; STEPCARE trial; temperature; adult; all cause mortality; Article; comatose patient; European Quality of Life 5 Dimensions Visual Analogue Scale; female; human; intensive care unit; intention to treat analysis; male; mean arterial pressure; multicenter study (topic); out of hospital cardiac arrest; outcome assessment; prognosis; quality of life; Rankin scale; resuscitation}},
  language     = {{eng}},
  number       = {{5}},
  publisher    = {{Blackwell Munksgaard}},
  series       = {{Acta Anaesthesiologica Scandinavica}},
  title        = {{Sedation, temperature and pressure after cardiac arrest and resuscitation—The STEPCARE trial: A statistical analysis plan}},
  url          = {{http://dx.doi.org/10.1111/aas.70033}},
  doi          = {{10.1111/aas.70033}},
  volume       = {{69}},
  year         = {{2025}},
}