Adult critically ill patients Other
Conditions
Interventions
A blocked randomization scheme with blocks of 4 patients will be used in this study. The code for randomization blinding is stored in the randomization tool, developed in FilemakerPro with restricted
Sponsors
Universitair Ziekenhuis Leuven
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained 2. Age >= 18 years 3. Patient expected to stay at the ICU for at least 5 days 4. The presence of a nasogastric feeding tube
Exclusion criteria
Exclusion criteria: 1. Therapy restriction code 2. Patients refusing blood transfusion upon ICU admission will be considered as having a therapy restriction upon admission and will not be included 3. Expected to die within 48 hours after screening (= moribund patients) 4. No arterial and central venous line, or expected to have one of these lines removed before the end of the study period (= not critically ill enough to be representative for the future target population). 5. Contraindication for enteral feeding 6. Readmission to the ICU after previous inclusion in the RCT 7. Inborn metabolic disease 8. Receiving ketogenic diet in ICU 9. Underweigt (BMI<20) or admitted with complications due to anorexia nervosa 10. Known to be pregnant or lactating 11. ICU admission with diabetic ketoacidosis or hyperosmolar hyperglycemic state 12. Acute or chronic liver failure 13. High glucose need to prevent spontaneous hypoglycemia 14. Metabolic acidosis (pH <7.30 and bicarbonate <18 mmol/l)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in plasma 3-hydroxybutyrate by at least 0.22 mmol/l following administration of enteral 3HHB, measured by LC-MS/MS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma levels of 3HHB and metabolites 3-hydroxybutyrate and 1,3-butanediol measured over time during (6-hour period) and after the intervention (12-hour period), measured by LC-MS/MS 2. Urine levels of 3HHB and metabolites 3-hydroxybutyrate and 1,3-butanediol over time during (6-hour period) and after the intervention (12-hour period), measured by LC-MS/MS 3. Plasma levels of cholesterol (HDL, LDL, total), triglycerides and free fatty acids over time during (6-hour period) and after the intervention (12-hour period), measured by commercial kits 4. Blood glucose concentrations during the 48 h study period, measured by blood-gas-analyzer 5. Incidence of severe (<40 mg/dl) hypoglycemia during the intervention window and until 12 h after stopping study infusion (3HHB or placebo), measured with a blood gas analyser in the ICU 6. Incidence of ketoacidosis during the intervention window and until 12 h after stopping the study infusion, measured with a ketone stick test on arterial blood in the ICU 7. Intolerance for the supplement (including abdominal discomfort or vomiting) during the intervention up until 48 hours after the last intervention, as reported by the patient or observed by the attending (study) nurse | — |
Countries
Belgium
Contacts
Public ContactLiese Mebis
Outcome results
None listed