ArticleActa anaesthesiologica Scandinavica2025
Sedation, temperature and pressure after cardiac arrest and resuscitation-The STEPCARE trial: A statistical analysis plan.
Article in Acta anaesthesiologica Scandinavica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed.
- Effects of Sedation, TEmperature and Pressure After Cardiac Arrest and REsuscitation on Major Adverse Kidney Events (STEPCARE-MAKE): A Protocol for a Pre-Planned Sub-Study of a Randomized Clinical Trial.Acta anaesthesiologica Scandinavica · 2026Article
- Early Prediction of Neurological Outcome After Cardiac Arrest-Rationale and Design of the Prospective International Observational EARLY-NEURO, a STEPCARE Substudy.Acta anaesthesiologica Scandinavica · 2026Observational
- Wolf Creek XVIII Part 7: strategies to optimize international collaborations in cardiac arrest research.Resuscitation plus · 2026Article
- Article
- Logistical Challenges in Platform Randomized Trials - Operational Realities That Curb the Promise of Efficiency.Clinical epidemiology · 2026Article
- Management of post-resuscitation vasoplegic shock: targets, strategies and outcomes.Critical care (London, England) · 2025Review
- Long-Term Outcomes After Cardiac Arrest: Protocol for the Extended Follow-Up Sub-Study of the STEPCARE Trial.Acta anaesthesiologica Scandinavica · 2025Article
- Accuracy of EEG Slow Wave Activity in Predicting Favorable Outcome in Patients With Hypoxic Brain Injury-A Protocol for a Substudy of the STEPCARE Trial.Acta anaesthesiologica Scandinavica · 2025Article
- A study of Professor Bellomo's contribution to cardiac arrest research.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2025Article
- Innate Immune Response After Cardiac Arrest (INNATUS): A Study Protocol for an Observational Single-Center Pilot Study.Acta anaesthesiologica Scandinavica · 2025Observational
- A Personal Reflection on the Late Rinaldo Bellomo, One of the Most Prolific Researchers in Intensive Care Medicine.Acta anaesthesiologica Scandinavica · 2025Article
- V-CARE (Virtual Care After REsuscitation): Protocol for a Randomized Feasibility Study of a Virtual Psychoeducational Intervention After Cardiac Arrest-A STEPCARE Sub-Study.Journal of clinical medicine · 2025Article
- Sedation, temperature and pressure after cardiac arrest and resuscitation-The STEPCARE trial: A statistical analysis plan.Acta anaesthesiologica Scandinavica · 2025Article
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Authors and funding
80 authors.
Funding
Abstract
backgroundBasic 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.
methodsThe 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.
conclusionThis 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.
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