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Multicenter Study
. 2025 May;69(5):e70033.
doi: 10.1111/aas.70033.

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

C B Kamp  1   2 J Dankiewicz  3 M Harboe Olsen  1   4 J Holgersson  5 M Saxena  6   7 P Young  8   9   10   11 V H Niemelä  12 J Hästbacka  13 H Levin  14   15 G Lilja  16   17 M Moseby-Knappe  14   16 M Tiainen  18 M Reinikainen  19   20 A Ceric  21 J Johnsson  22 J Undén  23   24 J Düring  21 A Lybeck  24 D Rodriguez-Santos  25 A Lundin  26 J Kåhlin  27   28 J Grip  27   29 E Lotman  30 L Romundstad  31   32 P Seidel  33 P Stammet  34 T Graf  35   36 A Mengel  37   38 C Leithner  39 J Nee  40 P Drúwe  41 K Ameloot  42 M P Wise  43 P J McGuigan  44   45 A Ratcliffe  46 J Cole  47 J White  48 N Pareek  49   50 G Glover  51 R Handslip  52 A Proudfoot  53 M Thomas  54 D Pogson  55 T R Keeble  56   57 A Nichol  58   59   60 M Haenggi  61 M P Hilty  61 M Iten  62 C Schrag  63 M Nafi  64 M Joannidis  65 C Robba  66   67 T Pellis  68 J Belohlavek  69   70   71 O Smid  69   70 D Rob  69   70 Y Arabi  72 S Buabbas  73 C Yew Woon  74   75   76 Q Li  77 M Reade  78 A Delaney  78   79   80 B Venkatesh  81 N Hammond  79   82 F Bass  77   83 A Aneman  84   85   86 A Stewart  87 L Navarra  9 B Crichton  9 D Knight  88 A Williams  89 J Tirkkonen  90 T Oksanen  11 T Kaakinen  91   92 S Bendel  18   19 H Friberg  93   94 T Cronberg  15   16 M B Skrifvars  12 N Nielsen  5   94 J C Jakobsen  1   2
Affiliations
Multicenter Study

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

C B Kamp et al. Acta Anaesthesiol Scand. 2025 May.

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.

Keywords: STEPCARE trial; blood pressure; cardiac arrest; sedation; statistical analysis; temperature.

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Conflict of interest statement

Pellis T. received lecture fees from BD. Leithner C received research support from Laerdal Foundation. Glover G received consulting and speaker fees from Sedana Medical; BD; and research grants from Mindray and Sedana Medical. Nee J received honorarium and travel costs for presentations from BD BARD and Xenios AG. Pareek N received Abbott Vascular—Honoraria, Consultancy, Educational Grants, and NIPRO—Honoraria, Shockwave Medical—Consultancy. Skrifvars M received a speaker's fee from BARD Medical (Ireland) 2022 and he is a member of the editorial board of Acta Anaesthesiologica Scandinavica.

References

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