ICU sedation, delirium & recovery

Intensive Care Platform Trial (INCEPT): The Intensive Care Platform Trial—Design and protocol

Acta Anaesthesiol ScandPublished Protocol of an adaptive platform randomised controlled trial

Study context

Population
Adults acutely admitted to intensive care unit (ICUs)
Planned comparison
Comparable groups of commonly used ICU interventions nested in domains
Primary endpoint
Each domain will use one of these core outcomes as the primary outcome
Methodological detailsinvestigator-initiated, pragmatic, embedded, multifactorial, international, Bayesian, response-adaptive randomisation, Interventions open-label or masked; new domains continuously added, Bayesian analysis with neutral, minimally informative or sceptical priors, adjusted for prognostic baseline variables, ITT populations, Domains and arms may stop for superiority/inferiority, practical equivalence or futility per pre-specified adaptation rules or at maximum sample sizes
  • Investigator-initiated
  • Pragmatic
  • Embedded
  • Multifactorial
  • International
  • Bayesian
  • Response-adaptive randomisation
  • Interventions open-label or masked; new domains continuously added
  • Bayesian analysis with neutral, minimally informative or sceptical priors, adjusted for prognostic baseline variables, ITT populations
  • Domains and arms may stop for superiority/inferiority, practical equivalence or futility per pre-specified adaptation rules or at maximum sample sizes

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

Original publication

INCEPT: The Intensive Care Platform Trial—Design and protocol. Acta Anaesthesiol Scand. Published 14 March 2025. doi:10.1111/aas.70023

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