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NCT07738536

Overview

NCT ID: NCT07738536
Lead Sponsor: Karolinska University HospitalOTHER
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.
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Aug 31, 2026Estimated
Primary Completion Date: Jul 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Adult (≥18 years).

ICU admission (index admission to the participating ICU).

Exclusion Criteria:

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,

Pregnancy,

Exclusive end-of-life care (no other treatment goal than comfort care for end of life),

Organ donor,

Prior enrolment in this trial during the same hospitalisation,

Patients with a metabolic disease requiring specific diet and patients with clinical need for a ketogenic diet.

Patients already enrolled in other interventional studies on nutrition, intravenous fluids, phosphate supplementation or hormonal therapies that influence glucose homeostasis.

Inclusion not possible due to site-specific regulatory issues regarding the ethical approval or informed consent procedure.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 200Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Martin Sundström Rehal, MD PhDContact
martin.sundstrom-rehal@regionstockholm.se

Similar Studies

Participant Group/Arms

InterventionExperimental

Intensive care unit patients with policy allocation to delayed medical nutrition therapy in main study: no enteral nutrition, parenteral nutrition or maintenance glucose solutions for first 72 hours.

Other: Delayed nutrition

ControlActive Comparator

Intensive care unit patients with policy allocation to standard care in main study: nutritional management according to regular unit protocols.

Other: Standard nutrition

Healthy reference controlsActive Comparator

Healthy subjects undergoing 72 hour fast with same blood sampling procedure as in ICU.

Other: Fasting