Abstract
BACKGROUND: Intravenous albumin is used for resuscitation of adult intensive care unit (ICU) patients with shock and substitution in those with hypoalbuminemia, which is common in critically ill patients. There is, however, substantial clinical practice variation as it is uncertain if albumin use improves patient-important outcomes. METHODS: The INCEPT-Albumin domain is an investigator-initiated, open-label domain with an integrated feasibility phase on the international, pragmatic, parallel-group, randomised, embedded, multifactorial, adaptive Intensive Care Platform Trial (INCEPT). Adult acutely admitted ICU patients with shock irrespective of its cause will be randomised to albumin versus no albumin use for resuscitation and substitution while in the ICU for a maximum of 90 days. The primary outcome is days alive without life support at 30 days. Secondary outcomes include 30-, 90-, and 180-day all-cause mortality; days alive without life support at 90 days; days alive out of hospital at 30 and 90 days; days free of delirium at 30 days; health-related quality of life and cognitive function at 180 days; and serious adverse reactions at 30 and 90 days. Analyses will primarily be conducted in the intention-to-treat population using Bayesian statistical models with neutral, weakly informative priors. We will assess feasibility after 200 participants and conduct adaptive analyses after follow-up for the primary outcome of 1000 participants and every additional 250 participants to a maximum of 10,000, with adaptive stopping for superiority/inferiority and practical equivalence (mean difference in the primary outcome < 1 day). Allocation will initially be equal, followed by response-adaptive randomisation with minimum 40% allocation to each arm. Expected sample sizes across different scenarios range from 1137 to 3547 participants, with approximately 100% probabilities of conclusiveness across scenarios. CONCLUSIONS: INCEPT-Albumin will with high probability provide conclusive results and inform clinical practice regarding albumin versus no albumin use in adult acutely admitted ICU patients with shock.