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INCEPT: The Intensive Care Platform Trial-Design and protocol.
Anders Granholm1,2,3, Morten Hylander Møller1,3,4, Benjamin Skov Kaas-Hansen1,2,3
1Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Acta Anaesthesiologica Scandinavica
|March 14, 2025
Summary
The Intensive Care Platform Trial (INCEPT) uses an adaptive design to efficiently compare interventions in adult intensive care units (ICUs). This approach aims to provide faster, more conclusive evidence to improve patient outcomes.
Area of Science:
- Critical Care Medicine
- Clinical Trials Methodology
- Evidence-Based Practice
Background:
- Adult intensive care units (ICUs) utilize numerous interventions with limited high-certainty evidence supporting their efficacy.
- Conventional randomized clinical trials (RCTs) are often resource-intensive, inflexible, and may yield inconclusive results.
- Adaptive platform trials offer a potential solution to enhance efficiency and accelerate evidence generation in critical care.
Purpose of the Study:
- To introduce the Intensive Care Platform Trial (INCEPT), an adaptive platform designed for rigorous evaluation of interventions in adult ICUs.
- To outline the pragmatic, international, and multifactorial design of INCEPT, accommodating multiple interventions and continuous addition of new research domains.
- To detail the core outcomes and statistical methodologies, including Bayesian approaches and response-adaptive randomization, employed by INCEPT.
Main Methods:
- INCEPT is a pragmatic, randomized, embedded, multifactorial, international, adaptive platform trial for adult ICU patients.
- It assesses multiple interventions within distinct domains, utilizing core outcomes such as mortality, days alive without life support, and quality of life.
- Bayesian statistical methods, with potential for response-adaptive randomization, are employed to efficiently analyze accumulating data and adapt trial progression.
Main Results:
- The adaptive platform design allows for continuous enrollment and assessment of interventions.
- Pre-specified rules enable early stopping of intervention arms for superiority, inferiority, equivalence, or futility.
- Response-adaptive randomization aims to allocate more participants to more promising interventions.
Conclusions:
- INCEPT offers an efficient, pragmatic, and flexible framework for comparing multiple interventions in adult ICU settings.
- The adaptive design facilitates the use of accumulating data to refine treatments for future patients.
- INCEPT is expected to yield high-certainty evidence, directly influencing clinical practice and improving patient outcomes.
