Sedation, temperature and pressure after cardiac arrest and resuscitation—The <scp>STEPCARE</scp> trial: A statistical analysis plan
Caroline Barkholt Kamp, Josef Dankiewicz, Markus Harboe Olsen, Jan Holgersson, Manoj Saxena, Paul J. Young, Ville Niemelä, Johanna Hästbacka, Hilton Levin, Gisela Lilja, Marion Moseby‐Knappe, Marjaana Tiainen, Matti Reinikainen, Ameldina Ceric, J. Johnsson, Johan Undén, Joachim Düring, Anna Lybeck, Daniel Rodriguez-Santos, Andreas Lundin, Jessica Kåhlin, Jonathan Grip, Eno-Martin Lotman, Luis Romundstad, Peter Seidel, Pascal Stammet, Tobias Graf, Annerose Mengel, Christoph Leithner, Jens Nee, Patrick Druwé, Koen Ameloot, Matt P. Wise, Peter McGuigan, A. Hall Ratcliffe, Jennifer L. Cole, Judith White, Nilesh Pareek, Guy Glover, Rhodri Handslip, Alastair Proudfoot, Matthew Thomas, David Pogson, Thomas Keeble, Alistair D. Nichol, Matthias Hænggi, Matthias P. Hilty, Manuela Iten, Claudia Schrag, Matteo Nafi, Michael Joannidis, Chiara Robba, Tommaso Pellis, Jan Bělohlávek, O. Smid, Daniel Rob, Yaseen M. Arabi, S. Buabbas, Chia Yew Woon, Qing Li, Michael C. Reade, Anthony Delaney, Balasubramanian Venkatesh, Naomi Hammond, Frances Bass, Anders Åneman, A Stewart, L Navarra, Brian Crichton, David Knight, Alan Williams, Joonas Tirkkonen, T. Oksanen, Timo Kaakinen, Stepani Bendel, Hans Friberg, Tobias Cronberg, Markus B. Skrifvars, Niklas Nielsen, Janus Christian Jakobsen
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.