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Ketosis, Immune Function and Metabolic Adaptation in Response to Short-term Fasting in Critical Illness
Sponsor: Karolinska University Hospital
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.
Official title: KETOsis, Immune Function and Metabolic Adaptation in Response to Short-Term Fasting in Critical Illness (KETO-FAST): A Translational Substudy of the FAST-ICU Cluster-randomized Cross-over Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-08-31
Completion Date
2027-07-31
Last Updated
2026-09-01
Healthy Volunteers
Yes
Interventions
Delayed nutrition
Intervention Policy (A): Withhold nutrition and glucose solutions (First 72 h) * No enteral nutrition (EN) and no parenteral nutrition (PN) for the first 72 hours from ICU admission time (t=0). * No glucose-containing maintenance IV solutions during the first 72 hours. Balanced crystalloids or normal saline permitted per clinical need. * 5% glucose solution permitted as vehicle for IV medications as necessary (according to local standard), or as treatment for hypernatremia * Oral intake permitted ad lib if the patient is awake, willing and able to eat safely. * Micronutrients: daily vitamins and trace elements are allowed per local practice. * Protein supplements are not allowed unless part of the standard oral diet. * Arterial or venous blood glucose measurement every 4h. * Rescue glucose will be administered according to local protocol. * After 72 hours, feeding transitions to usual care at clinician discretion (including EN/PN initiation and caloric/protein targets).
Standard nutrition
Control Policy (B): Standard of Care * Initiation and advancement of EN/PN and use of glucose-containing maintenance fluids per local practice from admission. * Arterial or venous blood glucose measurement every 4h. * Insulin and glycaemic control per local protocols.
Fasting
72-hour fasting period with water and non-caloric beverages.
Locations (1)
Karolinska University Hospital Huddinge
Stockholm, Sweden