Clinical Trial

Ketosis, Immune Function and Metabolic Adaptation in Response to Short-term Fasting in Critical Illness

Study acronym: KETO-FAST
Not Yet Recruiting
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Summary
KETO-FAST is a pre-planned translational substudy of the FAST-ICU cluster-randomized cross-over trial. The substudy will characterize ketone body production and associated metabolic, autophagy-related, and immune cellular responses during the first 72 hours after intensive care unit admission in critically ill patients exposed to delayed nutrition compared with patients receiving standard care. Patients enrolled in FAST-ICU at designated participating centers will undergo serial blood sampling during the first 72 hours after ICU admission. Plasma ketone body concentrations, targeted metabolomics, serum-induced cellular responses in vitro, leukocyte autophagy markers, and immune cell phenotypes and functional markers will be assessed. In addition, 10 healthy volunteers will perform a 72-hour fast with blood sampling to provide reference values from non-critically ill subjects.
Trial Details
NCT Number NCT07738536
Lead Sponsor Karolinska University Hospital
Collaborators: Tartu University Hospital
Conditions Critical Illness, Fasting State, Ketosis, Nutrition
Enrollment 200 participants
Start Date 2026-08-31
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-31