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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Adult (≥18 years).

ICU admission (index admission to the participating ICU).

Disqualifiers

The patient requires intravenous glucose infusion, enteral nutrition or parenteral nutrition according to the attending clinician's assessment,

Acute or acute-on-chronic liver failure

Moderate hypernatremia ( >150 mmol/L)

Diabetic ketoacidosis or hyperosmolar hyperglycemic state at admission,

Trial design

Treatments tested in this trial

  • Delayed nutrition
  • Standard nutrition
  • Fasting

Treatment groups

200 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Karolinska University Hospital

Lead sponsor

Tartu University Hospital

Collaborator