Hemodynamics, fluids & transfusion
Albumin for Adult Intensive Care Unit (ICU) Patients With Shock: Protocol for the Intensive Care Platform Trial (INCEPT) ‐Albumin Platform Trial Domain
Study context
- Population
- Adult acutely admitted ICU patients with shock irrespective of its causeexpected 1137 to 3547
- Planned comparison
- Albumin vs no albumin for resuscitation and substitution in the ICU
- Primary endpoint
- Days alive without life support
- Follow-up
- 30 days
Methodological detailsrandomised platform trial domain, investigator-initiated, open-label, integrated feasibility phase, international, pragmatic, parallel-group, embedded, multifactorial, adaptive, Bayesian, response-adaptive randomisation, Feasibility assessed after 200 participants; adaptive analyses after primary-outcome follow-up of 1000 participants and every additional 250 to a maximum of 10,000, Adaptive stopping for superiority/inferiority and practical equivalence (MD in primary outcome < 1 day), Equal allocation initially, then response-adaptive randomisation with minimum 40% allocation to each arm, Primary analysis in ITT population using Bayesian models with neutral, weakly informative priors
- Randomised platform trial domain
- Investigator-initiated
- Open-label
- Integrated feasibility phase
- International
- Pragmatic
- Parallel-group
- Embedded
- Multifactorial
- Adaptive
- Bayesian
- Response-adaptive randomisation
- Feasibility assessed after 200 participants; adaptive analyses after primary-outcome follow-up of 1000 participants and every additional 250 to a maximum of 10,000
- Adaptive stopping for superiority/inferiority and practical equivalence (MD in primary outcome < 1 day)
- Equal allocation initially, then response-adaptive randomisation with minimum 40% allocation to each arm
- Primary analysis in ITT population using Bayesian models with neutral, weakly informative priors
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Albumin for Adult ICU Patients With Shock: Protocol for the INCEPT ‐Albumin Platform Trial Domain. Acta Anaesthesiol Scand. Published 16 February 2026. doi:10.
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