Cardiac arrest & resuscitation

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

Acta Anaesthesiol ScandPublished Statistical analysis plan for the STEPCARE randomised trial

Study context

Population
Adults admitted to intensive care unit (ICU) comatose after resuscitation from OHCA
Planned comparison
Sedation, temperature and blood pressure strategies in three separate comparisons (SED-CARE, TEMP-CARE, MAP-CARE)
Primary endpoint
All-cause mortality
Follow-up
6 months after randomization
Methodological detailsmulticenter, parallel-group, factorial, superiority, intention-to-treat, Analyses performed independently by two statisticians, Prognosticators, outcome assessors, statisticians, data managers, steering group and manuscript writers blinded to allocation
  • Multicenter
  • Parallel-group
  • Factorial
  • Superiority
  • Intention-to-treat
  • Analyses performed independently by two statisticians
  • Prognosticators, outcome assessors, statisticians, data managers, steering group and manuscript writers blinded to allocation

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Sedation, temperature and pressure after cardiac arrest and resuscitation—The STEPCARE trial: A statistical analysis plan. Acta Anaesthesiol Scand. Published 10 April 2025. doi:10.1111/aas.70033

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